AzTrials
AzTrials

Crohn DiseasePhase 2/3ICONIC-CDNCT07196722

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2/3 study testing Icotrokinra in people with Crohn Disease, run by Janssen Research & Development, LLC at 395 sites in 28 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Icotrokinra
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,092 participants
Where
395 sitesin 28 countries
Study dates
3 Oct 2025to 6 Oct 2032
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
  • Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score >=220 but <=450 and either mean daily SF count >=4, or mean daily AP score >=2
  • Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD >= 6 for participants with colonic or ileocolonic disease, and SES-CD >= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments
  • A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests
  • Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy [ADT]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder [IR]) as defined in the protocol

Who cannot join

  • Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
  • Presence of a stoma or ostomy
  • Participants with presence of active fistulas may be included if there is no surgery needed
  • Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
  • Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization

Trial locations and contacts

395 sites in 28 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

395 sites in 28 countries

United States64 sites, 57 recruiting

  • Clinnova Research

    Anaheim, California, 92805

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

    Recruiting

  • Children's Center for Digestive Health Care

    Atlanta, Georgia, 30342

    Recruiting

  • The University of Texas at Austin

    Austin, Texas, 78712

    Recruiting

  • Alliance Research Institute, LLC - Canoga Park

    Canoga Park, California, 91304

    Completed

  • Westchester Putnam Gastroenterology

    Carmel, New York, 10512

    Recruiting

  • DFW Clinical Trials

    Carrollton, Texas, 75010

    Recruiting

  • AZ Gastro Care

    Chandler, Arizona, 85206

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • Atrium Health

    Charlotte, North Carolina, 28204

    Recruiting

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

    Recruiting

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

    Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

    Recruiting

  • Southern California Research Center

    Coronado, California, 92118

    Recruiting

  • Tri-State Gastroenterology Assoc

    Crestview Hills, Kentucky, 41017

    Recruiting

  • American Institute of Research

    Cutler Bay, Florida, 33157

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Nuvance Health Danbury Hospital

    Danbury, Connecticut, 06810

    Completed

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland, 21061

    Recruiting

  • Susquehanna Research Group

    Harrisburg, Pennsylvania, 17110-3673

    Recruiting

  • Penn State Milton S Hershey Medical Ctr

    Hershey, Pennsylvania, 17033

    Recruiting

  • Victorium Clinical Research

    Houston, Texas, 77024

    Recruiting

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

    Recruiting

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

    Recruiting

  • Green Leaf Clinical Trials

    Jacksonville, Florida, 32258

    Completed

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana, 70503

    Recruiting

  • Florida Research Center Inc.

    Lakewood Rch, Florida, 34211

    Recruiting

  • Om Research, LLC 1

    Lancaster, California, 93534

    Recruiting

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

    Recruiting

  • TLC Clinical Research Inc

    Los Angeles, California, 90048

    Recruiting

  • GastroIntestinal Bioscience

    Los Angeles, California, 90067

    Recruiting

  • University of Louisville - MedCenter One

    Louisville, Kentucky, 40202

    Recruiting

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

    Recruiting

  • Gastroenterolgy Associates of Central GA

    Macon, Georgia, 31201

    Recruiting

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157-6575

    Recruiting

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Inflammatory Bowel Disease Center at NYU Langone

    New York, New York, 10016

    Recruiting

  • Manhattan Clinical Research LLC

    New York, New York, 10016

    Completed

  • Weill Cornell Medical College

    New York, New York, 10065

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Recruiting

  • New York Gastroenterology Associates

    New York, New York, 10075

    Recruiting

  • Hoag Memorial Hospital

    Newport Beach, California, 92658

    Recruiting

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73114

    Completed

  • Om Research, LLC 2

    Oxnard, California, 93030

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Jefferson Digestive Health Institute

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • The Oregon Clinic

    Portland, Oregon, 97220-9428

    Recruiting

  • University Gastroenterology

    Providence, Rhode Island, 02905

    Recruiting

  • Mayo Clinic 1

    Rochester, Minnesota, 55905

    Recruiting

  • Digestive Disease Associates

    Rock Hill, South Carolina, 29732

    Completed

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

    Recruiting

  • Clinical Applications Laboratories, Inc

    San Diego, California, 92103

    Completed

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94115

    Recruiting

  • Mayo Clinic

    Scottsdale, Arizona, 85259

    Recruiting

  • GI Alliance Southlake

    Southlake, Texas, 76092

    Recruiting

  • GI Alliance Tacoma

    Tacoma, Washington, 98405

    Recruiting

  • GCP Clinical Research

    Tampa, Florida, 33609

    Recruiting

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

    Recruiting

  • Delta Research Partners, LLC

    West Monroe, Louisiana, 71291

    Recruiting

  • Kansas Gastroenterology, LLC

    Wichita, Kansas, 67226

    Recruiting

Other trials in United States

China35 sites, 35 recruiting

  • Capital Medical University, Beijing Friendship Hospital

    Beijing, 100050

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, 410008

    Recruiting

  • The second Xiangya Hospital of Central South University

    Changsha, 410011

    Recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213003

    Recruiting

  • West China Hospital Si Chuan University

    Chengdu, 610041

    Recruiting

  • Chongqing General Hospital

    Chongqing, 400014

    Recruiting

  • The First People's Hospital of Foshan

    Foshan, 528000

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350004

    Recruiting

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510261

    Recruiting

  • The Sixth Affiliated Hospital Sun Yat sen University

    Guangzhou, 510655

    Recruiting

  • Affiliated Hospital of Hainan Medical University

    Haikou, 570102

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

    Recruiting

  • Huizhou Central People's Hospital

    Huizhou, 516001

    Recruiting

  • Jinhua municipal central hospital

    Jinhua, 321000

    Recruiting

  • Lanzhou University Second Hospital

    Lanzhou, 730030

    Recruiting

  • The first affiliated hospital of Henan University of science and technology

    Luoyang, 471003

    Recruiting

  • The affiliated hospital of Southwest Medical University

    Luzhou, 646000

    Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, 210000

    Recruiting

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing, 210004

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

    Recruiting

  • Ningbo medical center lihuili hospital

    Ningbo, 315000

    Recruiting

  • Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University

    Shanghai, 200023

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, 200040

    Recruiting

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

    Recruiting

  • Shengjing Hospital Of China Medical University

    Shenyang, 110022

    Recruiting

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, 518101

    Recruiting

  • Second Affiliated Hospital of Soochow University

    Suzhou, 215000

    Recruiting

  • The 2nd Affiliated Hospital & Yuying Children s Hospital Wenzhou Medical University

    Wenzhou, 325026

    Recruiting

  • The Central Hospital of Wuhan

    Wuhan, 430014

    Recruiting

  • Zhongshan Hospital, Xiamen University

    Xiamen, 361004

    Recruiting

  • Northern Jiangsu Peoples Hospital

    Yangzhou, 225001

    Recruiting

  • ZhuZhou Central Hospital

    Zhuzhou, 412007

    Recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563099

    Recruiting

Other trials in China

Japan35 sites, 34 recruiting

  • Juntendo University Hospital Urayasu

    Chiba, 279 0021

    Recruiting

  • Fukui Prefectural Hospital

    Fukui-shi, 910-8526

    Recruiting

  • Gamagori City Hospital

    Gamagōri, 443-8501

    Recruiting

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

    Recruiting

  • Matsuda Hospital

    Hamamatsu, 432-8061

    Recruiting

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734 8551

    Recruiting

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557

    Recruiting

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

    Recruiting

  • Matsuda Pediatrics Digestion Clinic

    Kanazawa, 920 0981

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, 920 8641

    Recruiting

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

    Recruiting

  • Saitama Medical Center

    Kawagoe, 350-8550

    Recruiting

  • Hospital of the University of Occupational and Environmental Health

    Kitakyushu, 807-8556

    Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

    Recruiting

  • Takano Hospital

    Kumamoto, 862-0971

    Recruiting

  • Kurume University Hospital

    Kurume, 830-0011

    Recruiting

  • Kyorin University Hospital

    Mitaka, 181-8611

    Recruiting

  • Takagi Clinic

    Miyagi, 981-3213

    Recruiting

  • Aichi Medical University Hospital

    Nagakute, 480-1195

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501

    Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501

    Recruiting

  • Nakagami Hospital

    Okinawa, 904-2195

    Recruiting

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

    Completed

  • National Hospital Organization Osaka National Hospital

    Osaka, 540 0006

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586

    Recruiting

  • Saga University Hospital

    Saga, 849 0937

    Recruiting

  • Toho University Sakura Medical Center

    Sakura, 285-0841

    Recruiting

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041

    Recruiting

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    Sapporo, 060-0033

    Recruiting

  • Sapporo IBD Clinic

    Sapporo, 064-0919

    Recruiting

  • Tohoku University Hospital

    Sendai, 980 8574

    Recruiting

  • National Center for Global Health and Medicine

    Shinjuku- Ku, 162-8655

    Recruiting

  • Tokyo Yamate Medical Center

    Shinjuku-ku, 169-0073

    Recruiting

  • National Hospital Organization Shizuoka Medical Center

    Sunto-gun, 411-8611

    Recruiting

Other trials in Japan

Poland30 sites, 30 recruiting

  • Centrum Medyczne Medis

    Bydgoszcz, 85 229

    Recruiting

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85 231

    Recruiting

  • Osrodek Badan Klinicznych CLINSANTE S C

    Bydgoszcz, 85 794

    Recruiting

  • Centrum Medyczne Plejady

    Krakow, 30 363

    Recruiting

  • Malopolskie Badania Kliniczne

    Krakow, 30-002

    Recruiting

  • Centrum Medyczne Promed

    Krakow, 31-513

    Recruiting

  • Uniwersytecki Szpital Kliniczny nr 4

    Lublin, 20 090

    Recruiting

  • Medrise Sp. z o.o.

    Lublin, 20 582

    Recruiting

  • Allmedica

    Nowy Targ, 34 400

    Recruiting

  • Medicus Zaniewski i Bilski

    Olsztyn, 10-684

    Recruiting

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45-819

    Recruiting

  • Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp z o o

    Poznan, 60 354

    Recruiting

  • NZOZZPS Termedica Centrum Badan Kliniczych

    Poznan, 60 681

    Recruiting

  • RiverMED

    Poznan, 61-441

    Recruiting

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

    Recruiting

  • Endoskopia Sp z o.o.

    Sopot, 81 756

    Recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

    Recruiting

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

    Recruiting

  • GASTROMED Sp. z o.o.

    Torun, 87 100

    Recruiting

  • Care Access Warszawa

    Warsaw, 00 719

    Recruiting

  • ETG Warszawa

    Warsaw, 02-677

    Recruiting

  • Medon Clinical Research

    Warsaw, 02-679

    Recruiting

  • WSD MEDI Clinical Sp. z o. o.

    Warsaw, 02-786

    Recruiting

  • Bodyclinic Sp. z o.o. sp. k

    Warsaw, 03 712

    Recruiting

  • Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

    Warsaw, 04 073

    Recruiting

  • Medical Network WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

    Recruiting

  • Centrum Medyczne Oporow

    Wroclaw, 52 416

    Recruiting

  • Przychodnia Vistamed

    Wroclaw, 53 149

    Recruiting

  • EMC Instytut Medyczny S A Penta Hospitals Przychodnie

    Wroclaw, 54-239

    Recruiting

  • ETG Zamosc

    Zamość, 22 400

    Recruiting

Other trials in Poland

Brazil26 sites, 26 recruiting

  • Faculdade de Medicina Universidade Federal de Minas Gerais

    Belo Horizonte, 30130 100

    Recruiting

  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, 18618-686

    Recruiting

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200 730

    Recruiting

  • Chronos Clinica Medica Ltda

    Brasília, 72145-450

    Recruiting

  • CDC - Centro Digestivo de Curitiba

    Curitiba, 80430 180

    Recruiting

  • ATO Terapias

    Fortaleza, 60140 025

    Recruiting

  • CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda

    Jaú, 17201 130

    Recruiting

  • Galileo Medical Research Ltda

    Juiz de Fora, 36033-318

    Recruiting

  • Cliged

    Macaé, 27910-020

    Recruiting

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062-000

    Recruiting

  • Complexo Hospitalar de Niteroi

    Niterói, 24030-103

    Recruiting

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903

    Recruiting

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-093

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, 90560-032

    Recruiting

  • Platano Centro De Pesquisa Clinica LTDA

    Recife, 52011 200

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    Ribeirão Preto, 14015 010

    Recruiting

  • Clinica Ibis Medicina Ltda

    Salvador, 41820-020

    Recruiting

  • Pesquisare Saude

    Santo André, 09080-110

    Recruiting

  • Irmandade da Santa Casa da Misericórdia de Santos

    Santos, 11075-101

    Recruiting

  • Funfarme Sjrp

    São José do Rio Preto, 15090-000

    Recruiting

  • BR Trials

    São Paulo, 01236030

    Recruiting

  • Solare Trials

    São Paulo, 01307-000

    Recruiting

  • Hospital Santa Catarina

    São Paulo, 01310 000

    Recruiting

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-900

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05651 901

    Recruiting

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 15500-269

    Recruiting

Other trials in Brazil

India19 sites, 19 recruiting

  • Mazumdar Shaw Medical Centre - Narayana Hrudayalaya Limited

    Bangalore, 560099

    Recruiting

  • Aster CMI Hospital

    Bengaluru, 560092

    Recruiting

  • SUM Ultimate Medicare

    Bhubaneswar, 751003

    Recruiting

  • Fortis Memorial Research Institute

    Gurugram, 122002

    Recruiting

  • Asian Institute Of Gastroenterology

    Hyderabad, 500032

    Recruiting

  • Yashoda Super Speciality Hospitals

    Hyderabad, 500082

    Recruiting

  • S. R. Kalla Memorial General Hospital

    Jaipur, 302001

    Recruiting

  • Lisie Hospital

    Kochi, 682018

    Recruiting

  • Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines

    Ludhiana, 141001

    Recruiting

  • Fortis Hospital

    Ludhiana, 141010

    Recruiting

  • P D Hinduja National Hospital and Medical Research Center

    Mumbai, 400016

    Recruiting

  • GB Pant Institute of Post Graduate Medical Education & Research

    New Delhi, 110002

    Recruiting

  • All India Institute of Medical Sciences

    New Delhi, 110029

    Recruiting

  • Sir Ganga Ram Hospital

    New Delhi, 110060

    Recruiting

  • Indraprastha Apollo Hospital

    New Delhi, 1100776

    Recruiting

  • All India Institute of Medical Sciences

    Patna, 801507

    Recruiting

  • Yashoda Super Speciality Hospitals 1

    Secunderabad, 500003

    Recruiting

  • SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

    Surat, 395002

    Recruiting

  • Gujarat Gastro and Vascular Hospital

    Surat, 395009

    Recruiting

Other trials in India

France14 sites, 13 recruiting

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

    Recruiting

  • CHU de Clermont Ferrand - Site Estaing

    Clermont-Ferrand, 63100

    Recruiting

  • APHP - Hopital Henri Mondor

    Créteil, 94000

    Recruiting

  • Institut Prive MICI Clinique des Cedres

    Échirolles, 38130

    Recruiting

  • CHU de Lille Hopital Claude Huriez

    Lille, 59037

    Recruiting

  • GHI Le Raincy Montfermeil

    Montfermeil, 93370

    Completed

  • CHU de Montpellier Hopital Saint Eloi

    Montpellier, 34090

    Recruiting

  • Jules Verne Clinic

    Nantes, 44300

    Recruiting

  • CHU de Nice Hopital de l Archet

    Nice, 06202

    Recruiting

  • Hopital Saint-Antoine

    Paris, 75012

    Recruiting

  • Hospices Civils de Lyon CHU Lyon Sud

    Pierre-Bénite, 69495

    Recruiting

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

    Recruiting

  • CHU Toulouse - Hopital de Rangueil

    Toulouse, 31400

    Recruiting

  • CHRU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54500

    Recruiting

Other trials in France

Turkey (Türkiye)13 sites, 13 recruiting

  • Hacettepe University Hospital

    Ankara, 06230

    Recruiting

  • Gazi University Hospital

    Ankara, 06560

    Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

    Recruiting

  • Antalya Training And Research Hospital

    Antalya, 07100

    Recruiting

  • Uludag Universitesi Tıp Fakultesi Hastanesi

    Bursa, 16059

    Recruiting

  • Koc University, School of Medicine, Koc University Hospital

    Istanbul, 34010

    Recruiting

  • Bezmialem Vakif University Medical Faculty Hospital

    Istanbul, 34093

    Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

    Recruiting

  • Ege Universitesi Tip Fakultesi

    Izmir, 35100

    Recruiting

  • Dokuz Eylul University Medical Faculty

    Izmir, 35330

    Recruiting

  • Izmir Sehir Hastanesi

    Izmir, 35540

    Recruiting

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

    Recruiting

  • Mersin University Medical Faculty

    Mersin, 33343

    Recruiting

Other trials in Turkey (Türkiye)

Germany12 sites, 12 recruiting

  • DRK Kliniken Berlin Westend

    Berlin, 14050

    Recruiting

  • Medizinisches Versorgungszentrum (MVZ) Dachau

    Dachau, 85221

    Recruiting

  • Universitaetsklinik Erlangen

    Erlangen, 91054

    Recruiting

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Praxisgemeinschaft Jerichow

    Jerichow, 39319

    Recruiting

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

    Recruiting

  • Eugastro GmbH

    Leipzig, 04103

    Recruiting

  • Praxis fuer Gastroenterologie

    Lübeck, 23560

    Recruiting

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339

    Recruiting

  • Universitaetsmedizin Rostock

    Rostock, 18057

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, 89081

    Recruiting

Other trials in Germany

South Korea12 sites, 12 recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Recruiting

  • Yeungnam University Hospital

    Daegu, 42415

    Recruiting

  • The Catholic University of Korea Daejeon St Mary's Hospital

    Daejeon, 34943

    Recruiting

  • Kyung Hee University Hospital

    Dongdaemun-gu, 02447

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • The Catholic university of Korea, St. Vincent's Hospital

    Suwon, 16247

    Recruiting

Other trials in South Korea

Czechia10 sites, 10 recruiting

  • Fakultni nemocnice Brno

    Brno, 62500

    Recruiting

  • Vojenska nemocnice Brno

    Brno, 636 00

    Recruiting

  • Centrum gastroenterologie a hepatologie s.r.o.

    Kladno, 27280

    Recruiting

  • PreventaMed, s.r.o.

    Olomouc, 77900

    Recruiting

  • Gastromedic, Ltd.

    Pardubice, 530 03

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 00

    Recruiting

  • AXON Clinical s.r.o.

    Prague, 140 00

    Recruiting

  • Clinoxus s r o

    Prague, 14000

    Recruiting

  • Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze

    Praha 1- Mala Strana, 118 33

    Recruiting

  • MUDr. Michal Konecny, Ph.D. s.r.o.

    Přerov, 750 02

    Recruiting

Other trials in Czechia

Hungary10 sites, 10 recruiting

  • Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz

    Békéscsaba, 5600

    Recruiting

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

    Recruiting

  • Semmelweis Egyetem 1

    Budapest, 1082

    Recruiting

  • Semmelweis Egyetem

    Budapest, 1083

    Recruiting

  • Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika

    Budapest, 1088

    Recruiting

  • Pannónia Magánorvosi Centrum Kft

    Budapest, 1136

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Recruiting

  • Szegedi Tudomanyegyetem Aok Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

    Recruiting

  • Clinfan Ltd. SMO

    Szekszárd, 7100

    Recruiting

  • Szent Borbala Hospital Tatabanya

    Tatabánya, 2800

    Recruiting

Other trials in Hungary

Israel10 sites, 8 recruiting

  • Ha'Emek Medical Center

    Afula, 1834111

    Recruiting

  • Assuta MC

    Ashdod, 7747629

    Completed

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300

    Completed

  • Bnai Zion Medical Center

    Haifa, 31048

    Recruiting

  • Rambam Medical Center

    Haifa, 3109601

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Recruiting

  • Galilee Medical Center

    Nahariya, 22100

    Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492

    Recruiting

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Recruiting

Other trials in Israel

Spain10 sites, 10 recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. de Cabuenes

    Gijón, 33394

    Recruiting

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007

    Recruiting

  • Hosp. Univ. de La Princesa

    Madrid, 28006

    Recruiting

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hosp. Virgen Macarena

    Seville, 41009

    Recruiting

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

    Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Canada9 sites, 7 recruiting

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

    Recruiting

  • South Edmonton Gastroenterology Research Clinic

    Edmonton, Alberta, Code: T6K

    Recruiting

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

    Recruiting

  • Viable Clinical Research

    Kentville, Nova Scotia, B4N 0A3

    Recruiting

  • London Digestive Disease Institute

    London, Ontario, N6K 1M6

    Recruiting

  • CHUM - Centre hospitalier universitaire de Montreal

    Montreal, Quebec, H2X 0C1

    Recruiting

  • ABP Research Services Corp.

    Oakville, Ontario, L6L 5L7

    Completed

  • Toronto Immune and Digestive Health Institute Inc

    Toronto, Ontario, M6A 3B4

    Completed

  • GIRI Gastrointestinal Research Institute

    Vancouver, British Columbia, V6Z 2K5

    Recruiting

Other trials in Canada

Greece9 sites, 9 recruiting

  • Evangelismos S A

    Athens, 106 76

    Recruiting

  • Hippokration Hospital

    Athens, 115 27

    Recruiting

  • Thoracic General Hospital Of Athens I Sotiria

    Athens, 11527

    Recruiting

  • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

    Athens, 12462

    Recruiting

  • University General Hospital of Heraklion

    Heraklion, 715 00

    Recruiting

  • Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon

    Nikaia, 184 54

    Recruiting

  • Tzanio General Hospital of Piraeus

    Piraeus, 185 36

    Recruiting

  • Theageneio Cancer Hospital

    Thessaloniki, 546 39

    Recruiting

  • Ippokratio General Hospital Of Thessaloniki

    Thessaloniki, 546 42

    Recruiting

Other trials in Greece

Italy9 sites, 9 recruiting

  • ARNAS G Brotzu

    Cagliari, 09121

    Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano

    Milan, 20122

    Recruiting

  • Ospedale San Raffaele di Milano

    Milan, 20132

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900

    Recruiting

  • Ospedale Sacro Cuore Negrar-Verona

    Negrar-Verona, 37024

    Recruiting

  • Azienda Ospedaliera San Camillo-Forlanini

    Roma, 00152

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

    Recruiting

Other trials in Italy

United Kingdom9 sites, 9 recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2GW

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Glasgow Royal Infirmary

    Glasgow, G31 2ER

    Recruiting

  • Fairfield General Hospital

    Greater Manchester, BL9 7TD

    Recruiting

  • Whipps Cross University Hospital

    London, E11 1NR

    Recruiting

  • Guy's Hospital

    London, SE1 9RT

    Recruiting

  • St Georges University Hospital NHS Foundation Trust

    London, SW17 0RE

    Recruiting

  • Whiston Hospital

    Rainhill, L35 5DR

    Recruiting

  • Stepping Hill Hospital

    Stockport, SK2 7JE

    Recruiting

Other trials in United Kingdom

Belgium8 sites, 8 recruiting

  • CHU Saint-Pierre

    Brussels, 1000

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

    Recruiting

  • AZ St. Lucas

    Ghent, 9000

    Recruiting

  • Ghent University Hospital

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, 4000

    Recruiting

  • AZ Oostende

    Ostend, 8400

    Recruiting

  • CHwapi

    Tournai, 7500

    Recruiting

Other trials in Belgium

Argentina7 sites, 7 recruiting

  • GEDYT

    AAI, C1425BGC

    Recruiting

  • Hospital Aleman

    Buenos Aires, 1119

    Recruiting

  • Hospital Britanico de Buenos Aires

    CABA, C1280AEB

    Recruiting

  • Clinica Universitaria Reina Fabiola

    Córdoba, X5004FHP

    Recruiting

  • Hospital Privado de Cordoba

    Córdoba, XX5016KEH

    Recruiting

  • Sanatorio Maipu

    Maipu, M5515

    Recruiting

  • HIGEA

    Mendoza, M5500

    Recruiting

Other trials in Argentina

Australia7 sites, 7 recruiting

  • Royal Adelaide Hospital

    Adelaide, 5000

    Recruiting

  • Monash Health

    Clayton, 3168

    Recruiting

  • Concord Repatriation General Hospital

    Concord, 2139

    Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, 6150

    Recruiting

  • John Hunter Hospital

    New Lambton Heights, 2305

    Recruiting

  • Mater Hospital Brisbane

    South Brisbane, 4101

    Recruiting

Other trials in Australia

Malaysia7 sites, 7 recruiting

  • Hospital Sultanah Bahiyah

    Alor Star, 05460

    Recruiting

  • Hospital Ampang

    Ampang, 68000

    Recruiting

  • Hospital Sultanah Aminah

    Johor Bahru, 80100

    Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 50603

    Recruiting

  • Sultan Ahmad Shah Medical Centre IIUM

    Kuantan, 25200

    Recruiting

  • Hospital Tuanku Jaafar

    Seremban, 70300

    Recruiting

Other trials in Malaysia

Sweden7 sites, 7 recruiting

  • Alingsas lasarett

    Allingsas, 441 83

    Recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

    Recruiting

  • Linkoping University Hospital

    Linköping, 581 85

    Recruiting

  • Orebro universitetssjukhus

    Örebro, 703 82

    Recruiting

  • Ersta sjukhus

    Stockholm, 116 30

    Recruiting

  • Karolinska Universitetssjukhuset Solna

    Stockholm, 171 76

    Recruiting

  • Akademiska Sjukhuset

    Uppsala, 751 85

    Recruiting

Other trials in Sweden

Portugal6 sites, 6 recruiting

  • Uls Braga - Hosp. Braga

    Braga, 4710 243

    Recruiting

  • Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

    Guimarães, 4835 044

    Recruiting

  • Hosp. Lusiadas Lisboa

    Lisbon, 1500-458

    Recruiting

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 028

    Recruiting

  • Uls Loures Odivelas - Hosp. Loures

    Loures, 2674-514

    Recruiting

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4050 385

    Recruiting

Other trials in Portugal

Romania6 sites, 6 recruiting

  • S C Delta Health Care S R L

    Bucharest, 014142

    Recruiting

  • Spitalul Clinic Colentina

    Bucharest, 020125

    Recruiting

  • Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva

    Cluj-Napoca, 400061

    Recruiting

  • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor

    Cluj-Napoca, 400394

    Recruiting

  • Gastromed S R L

    Constanța, 900600

    Recruiting

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

    Recruiting

Other trials in Romania

Taiwan5 sites, 5 recruiting

  • Changhua Christian Hospital

    Changhua, 500

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

    Recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

  • Mackay Memorial Hospital

    Taipei, 104

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Netherlands4 sites, 4 recruiting

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV

    Recruiting

  • Maastricht UMC

    Maastricht, 6229 HX

    Recruiting

  • Radboud Umcn

    Nijmegen, 6525 GA

    Recruiting

  • Franciscus Gasthuis & Vlietland

    Rotterdam, 3045 PM

    Recruiting

Other trials in Netherlands

Switzerland2 sites, 2 recruiting

  • Inselspital Universitatsspital Bern

    Bern, 3010

    Recruiting

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

    Recruiting

Other trials in Switzerland

About this study

Official title: A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Conditions
Crohn Disease
Being tested
Icotrokinra, Placebo
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IcotrokinraDrug

    Also called JNJ-77242113

    Icotrokinra will be administered orally, daily.

  • PlaceboDrug

    Matching placebo will be administered orally, daily.

Study groups in NCT07196722
Study groupRoleWhat they receive
Induction Study 1: Icotrokinra Dose 1ExperimentalParticipants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Receives: Drug: Icotrokinra
Induction Study 1: Icotrokinra Dose 2ExperimentalParticipants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Receives: Drug: Icotrokinra
Induction Study 1: PlaceboPlacebo comparatorParticipants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Receives: Drug: Placebo
Induction Study 2: IcotrokinraExperimentalParticipants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Receives: Drug: Icotrokinra
Induction Study 2: PlaceboPlacebo comparatorParticipants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Receives: Drug: Placebo
Maintenance Study: Icotrokinra Dose 1ExperimentalParticipants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).
Receives: Drug: Icotrokinra
Maintenance Study: Icotrokinra Dose 2ExperimentalParticipants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Receives: Drug: Icotrokinra
Maintenance Study: PlaceboPlacebo comparatorParticipants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12. Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Receives: Drug: Icotrokinra; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Induction Study 1: Number of Participants with Clinical Response at Week 12

    Clinical response is defined as a greater than or equal to (>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 12

  2. Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)

    Clinical remission is defined as CDAI score less than (<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 12

  3. Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)

    Endoscopic response is defined as greater than (>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

    Measured: At Week 12

  4. Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)

    Clinical remission is defined as CDAI score < 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 40

  5. Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)

    Endoscopic response is defined as > 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

    Measured: At Week 40

Secondary outcomes (24)

  1. Induction Study 1: Number of Participants with Clinical Remission at Week 12

    Clinical remission is defined as CDAI score < 150. CDAI scores ranging from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 12

  2. Induction Study 1: Number of Participants with Endoscopic Response at Week 12

    Endoscopic response is defined as > 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

    Measured: At Week 12

  3. Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

    Measured: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)

  4. Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12

    PRO-2 remission is defined as an abdominal pain (AP) mean daily score less than or equal to (<=) 1 and stool frequency (SF) mean daily score <= 2.8, and no worsening of AP or SF from baseline.

    Measured: At Week 12

  5. Induction Study 2: Number of Participants with Clinical Response at Week 12

    Clinical response is defined as a >= 100-point reduction from baseline in CDAI score.

    Measured: At Week 12

  6. Induction Study 2: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 12

    Clinical remission is defined as CDAI score < 150. Endoscopic response is defined as > 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.

    Measured: At Week 12

  7. Induction Study 2: Number of Participants with Clinical Response at Week 4

    Clinical response is defined as a >= 100-point reduction from baseline in CDAI score.

    Measured: At Week 4

  8. Induction Study 2: Number of Participants with Endoscopic Remission at Week 12

    Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual component.

    Measured: At Week 12

  9. Induction Study 2: Number of Participants with Deep Remission at Week 12

    Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score < 150-point. Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual component.

    Measured: At Week 12

  10. Induction Study 2: Number of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12

    IBDQ remission is defined as IBDQ score >= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Measured: At Week 12

  11. Induction Study 2: Number of Participants with Fatigue Response at Week 12

    Fatigue response is defined as a >= 7 point reduction in the patient reported outcomes measurement information system (PROMIS)-Fatigue Short Form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.

    Measured: At Week 12

  12. Induction Study 2: Number of Participants with Clinical Remission at Week 4

    Clinical remission is defined as CDAI score< 150.

    Measured: At Week 4

  13. Induction Study 2: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 12

    Histologic remission is defined as a Robarts Histopathology Index score <=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.

    Measured: At Week 12

  14. Induction Study 2: Number of Participants with AEs and SAEs

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

    Measured: Up to 4 weeks after last dose of study drug (i.e., up to Week 16)

  15. Maintenance Study: Number of Participants with PRO-2 remission at Week 40

    PRO-2 remission is defined as an abdominal pain (AP) mean daily score <= 1 and stool frequency (SF) mean daily score <= 2.8, and no worsening of AP or SF from baseline.

    Measured: At Week 40

  16. Maintenance Study: Number of Participants with Endoscopic Remission at Week 40

    Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual component.

    Measured: At Week 40

  17. Maintenance Study: Number of Participants with 90-Day Corticosteroid-Free Clinical Remission at Week 40

    90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for at least 90 days prior to the visit. Clinical remission is defined as CDAI score < 150.

    Measured: At Week 40

  18. Maintenance Study: Number of Participants with Maintenance of Clinical Remission at Week 40

    Participants with clinical remission at Week 40 among those with clinical remission at Week 0 of the maintenance study will be analyzed. Clinical remission is defined as CDAI score < 150.

    Measured: At Week 40

  19. Maintenance Study: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 40

    Clinical remission is defined as CDAI score < 150. Endoscopic response is defined as > 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.

    Measured: At Week 40

  20. Maintenance Study: Number of Participants with Deep Remission at Week 40

    Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score < 150. Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual component.

    Measured: At Week 40

  21. Maintenance Study: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 40

    Histologic remission is defined as a Robarts Histopathology Index score <=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score >1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.

    Measured: At Week 40

  22. Maintenance Study: Number of Participants with IBDQ Remission at Week 40

    IBDQ remission is defined as IBDQ score >= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific HRQoL across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Measured: At Week 40

  23. Maintenance Study: Number of Participants with Fatigue Response at Week 40

    Fatigue response is defined as a >= 7 point reduction in the PROMIS-Fatigue Short Form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.

    Measured: At Week 40

  24. Maintenance Study : Number of Participants with AEs and SAEs

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

    Measured: Up to 4 weeks after last dose of study drug (i.e., up to Week 44)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start3 Oct 2025
  3. Primary completion19 Sep 2028 (estimated)
  4. Study completion6 Oct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,092 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07196722
Sponsor's protocol ID
77242113CRD3001
Other IDs
2025-521382-27-00, 2025
Acronym
ICONIC-CD
Status last verified
Nov 2026
First submitted
22 Sep 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Icotrokinra in people with Crohn Disease, run by Janssen Research & Development, LLC at 395 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 395 sites in United States, China, Japan, Poland, Brazil and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction Study 1: Number of Participants with Clinical Response at Week 12 (time frame: At Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07196722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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