AzTrials
AzTrials

Colitis, UlcerativePhase 3ASTRONCT05528510

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 study testing Guselkumab Dose 1, Guselkumab Dose 2 and Guselkumab Dose 3 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 236 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis, Ulcerative
What is being tested?
Guselkumab Dose 1, Guselkumab Dose 2 and Guselkumab Dose 3
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
418 participants
Where
236 sitesin 25 countries
Study dates
13 Sep 2022to 6 Oct 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed informed consent form
  • 18 years of age or older
  • Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
  • Moderately to severely active UC as per the modified Mayo score
  • Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol

Who cannot join

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
  • Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
  • Receiving prohibited medications and treatments
  • UC limited to the rectum only
  • Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection

Trial locations and contacts

236 sites in 25 countries.

236 sites in 25 countries

United States32 sites

  • Om Research LLC 1

    Apple Valley, California, 92307

  • Digestive Healthcare of Georgia, P.C

    Atlanta, Georgia, 30309

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7080

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Gastro Florida

    Clearwater, Florida, 33762

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45415

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48334

  • Peters Medical Research

    High Point, North Carolina, 27260

  • Smart Medical Research

    Hollis, New York, 11423

  • I.H.S. Health. LLC

    Kissimmee, Florida, 34741

  • Om Research LLC

    Lancaster, California, 93534

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340

  • Gastroenterology Associates of Central GA

    Macon, Georgia, 31201

  • Columbus Clinical Services LLC

    Miami, Florida, 33125

  • Vista Health Research, LLC

    Miami, Florida, 33176

  • Care Access Research, Ogden

    Ogden, Utah, 84403

  • Gastroenterology Associates of Orangeburg, SC

    Orangeburg, South Carolina, 29118

  • Orlando Health

    Orlando, Florida, 32806

  • Allegheny General Hospital of Research

    Pittsburgh, Pennsylvania, 15224

  • Gastroenterology Associates

    Salt Lake City, Utah, 84124

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

  • UT Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Theia Clincial Research, LLC

    Temple Terrace, Florida, 34209

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Frontier Clinical Research

    Uniontown, Pennsylvania, 15401

  • Victoria Gastroenterology

    Victoria, Texas, 77407

  • Gastro Intestinal Research Institute of Northern Ohio LLC

    Westlake, Ohio, 44145

Other trials in United States

Japan32 sites

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113-8510

  • Ginza central clinic

    Chūōku, 1040061

  • Sai Gastroenterology Proctology

    Fujiidera-shi, 583-0027

  • Fukuoka University Hospital

    Fukuoka, 814 0180

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

  • Hachinohe City Hospital

    Hachinohe, 031-8555

  • Tokai University Hachioji Hospital

    Hachiōji, 192-0032

  • Matsuda Hospital

    Hamamatsu, 432-8061

  • National Hospital Organization Mito Medical Center

    Higashiibaraki-gun, 311-3193

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, 920-8650

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

  • Kyushu Rosai Hospital

    Kitakyushu, 800-0296

  • Kumagaya General Hospital

    Kumagaya-shi, 360-8567

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure, 737-0023

  • Tokushukai Chiba-Nishi General Hospital

    Matsudo, 270-2251

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701

  • Yokoyama IBD Clinic

    Nagoya, 460-0022

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, 870-0823

  • Okayama Saiseikai General Hospital

    Okayama, 700-0013

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • Japanese Red Cross Osaka Hospital

    Osaka, 543 8555

  • Kindai University Hospital

    Ōsaka-sayama, 589-8511

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku Ku, 162 8655

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575

  • National Hospital Organization Shizuoka Medical Center

    Sunto-gun, 411-8611

  • Juntendo University Hospital Urayasu

    Urayasu, 279-0021

  • Kanke Gastrointestinal Clinic

    Utsunomiya, 320-0003

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

China25 sites

  • China Japan Friendship Hospital

    Beijing, 100029

  • Peking University Third Hospital

    Beijing, 100191

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Chongqing General Hospital

    Chongqing, 400014

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, 341000

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510260

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, 510280

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Jinhua municipal central hospital

    Jinhua, 321009

  • Lanzhou University Second Hospital

    Lanzhou, 730030

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

    Luoyang, 471003

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

  • Shanghai East Hospital

    Shanghai, 200123

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, 518101

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 050004

  • Taihe Hospital

    Shiyan, 442000

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Wuxi People s Hospital

    Wuxi, 214023

  • General Hospital of Ningxia Medical Hospital

    Yinchuan, 750011

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450014

Other trials in China

Poland16 sites

  • Gastromed Kralisz Romatowski Stachurska Sp. j.

    Bialystok, 15-322

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Medyczne Lukamed Sp z o o 1

    Chojnice, 89 600

  • Centrum Medyczne Lukamed Sp z o o

    Chojnice, 89 600

  • Centrum Medyczne Plejady

    Krakow, 30 363

  • Centrum Medyczne Promed

    Krakow, 31-513

  • Zespol Poradni Specjalistycznych REUMED Filia nr 2

    Lublin, 20-582

  • EMC Instytut Medyczny SA PL CERTUS

    Poznan, 60 309

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • GASTROMED Sp. z o.o.

    Torun, 87 100

  • Bodyclinic Sp. z o.o. sp. k

    Warsaw, 03 712

  • Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501

  • Przychodnia Vistamed

    Wroclaw, 53 149

  • Melita Medical Sp. z o.o.

    Wroclaw, 53 611

  • Pro Life Medica Sp z o o ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Brazil14 sites

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

    Botucatu, 18618-686

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200-730

  • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

    Campinas, 13060-904

  • CDC - Centro Digestivo de Curitiba

    Curitiba, 80430-180

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

    Jaú, 17201 130

  • Galileo Medical Research Ltda

    Juiz de Fora, 36033-318

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430-001

  • CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao

    Salvador, 41500-300

  • Pesquisare Saude

    Santo André, 09080-110

  • Kaiser Hospta

    São José do Rio Preto, 15015-110

  • BR TRIALS Ensaios Clinicos e Consultoria Ltda

    São Paulo, 01236030

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 15500-269

Other trials in Brazil

France13 sites

  • CHRU Besancon Hopital Jean Minjoz

    Besançon, 25030

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270

  • CHRU Montpellier - Hopital Saint-Eloi

    Montpellier, 34295 Cede

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200

  • CHU de Nice Hopital de l Archet

    Nice, 06202

  • Polyclinique Du Grand Sud

    Nîmes, 30932

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604

  • Hospices Civils de Lyon HCL

    Pierre-Bénite, 69495

  • CHU de Reims

    Reims, 51092

  • Hopital d'Instruction des Armees BEGIN

    Saint-Mandé, 94160

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • CHU Rangueil

    Toulouse, 31059

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

South Korea11 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Yeungnam University Hospital

    Daegu, 42415

  • National Cancer Center

    Goyang-si, 10408

  • Chosun university hospital

    Gwangju, 61453

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • Chung-Ang University Hospital

    Seoul, 06973

  • Kyung Hee University Hospital

    Seoul, 130 050

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

    Suwon, 16247

Other trials in South Korea

Mexico10 sites

  • SCIENTIA Investigacion Clinica SC

    Chihuahua City, 31207

  • Clinica de Investigacion en Reumatologia y Obesidad

    Guadalajara, 44650

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Clinicos Asociados BOCM, SC

    Mexico City, 03300

  • Centro de Investigacion Clinica Acelerada S.C

    Mexico City, 07369

  • Hospital Médica Sur Tlalpan

    Mexico City, 14050

  • Centro Regiomontano de Estudios Clínicos Roma S.C.

    Monterrey, 64610

  • Fundacion Santos Y De La Garza Evia IBP

    Monterrey, 64710

  • Clinical Research Institute Saltillo S.A. de C.V.

    Saltillo, 25020

  • Oncare

    San Pedro Garza García, 66220

Other trials in Mexico

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Monash Health

    Clayton, 3168

  • Royal Brisbane and Women's Hospital

    Herston, 4029

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Royal Melbourne Hospital

    Parkville, 3050

  • IBD Clinical Trials Mater Research

    South Brisbane, 4101

  • The Queen Elizabeth Hospital

    Woodville South, 5011

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Argentina8 sites

  • Cer Instituto Medico

    Buenos Aires, B1878DVB

  • Hospital General de Agudos José Maria Ramos Mejía

    Buenos Aires, C1221ADC

  • Clinica Adventista Belgrano

    Ciudad de Buenos Aires, C1430EGF

  • Sanatorio Duarte Quiroz

    Córdoba, X5002AOQ

  • Hospital Privado Universitario De Cordoba

    Córdoba, X5016KEH

  • Hospital Italiano de La Plata

    La Plata, B1900AXI

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK

  • Hospital Provincial del Centenario

    Rosario, S2000KDS

Other trials in Argentina

Israel7 sites

  • Ha'Emek Medical Center

    Afula, 1834111

  • Bnai Zion Medical Center

    Haifa, 3339419

  • Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center - Jerusalem, ISRAEL

    Jerusalem, 91031

  • Lev Talpiot Clinic

    Jerusalem, 93624

  • Galilee Medical Center

    Nahariya, 2210001

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

Other trials in Israel

Czechia6 sites

  • Nemocnice Ceske Budejovice a s

    České Budějovice, 37001

  • Gastroenterologie, s.r.o., Hradec Kralove

    Hradec Kralova, 500 02

  • Artroscan s r o

    Ostrava, 722 00

  • Synexus Czech s.r.o.

    Prague, 120 00

  • AXON Clinical s.r.o.

    Prague, 15000

  • ISCARE a.s.

    Prague, 170 04

Other trials in Czechia

Malaysia6 sites

  • Hospital Selayang

    Batu Caves, 68100

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Sultanah Aminah

    Johor Bahru, 80100

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Umum Sarawak

    Kuching, 93586

  • Hospital Tuanku Jaafar

    Seremban, 70300

Other trials in Malaysia

Germany5 sites

  • Medizinisches Versorgungszentrum (MVZ) Dachau

    Dachau, 85221

  • MVZ Sanaklinikum Duisburg

    Duisburg, 47055

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Praxisgemeinschaft Jerichow

    Jerichow, 39319

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339

Other trials in Germany

India5 sites

  • Fortis Memorial Research Institute

    Gurugram, 122002

  • Asian Institute Of Gastroenterology

    Hyderabad, 500032

  • Kasturba Medical College Hospital

    Manipal, 576104

  • P D Hinduja National Hospital and Medical Research Center

    Mumbai, 400016

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

    Surat, 395002

Other trials in India

New Zealand5 sites

  • Hutt Hospital

    Boulcott, 5010

  • Christchurch Hospital

    Christchurch, 8011

  • Dunedin Hospital

    Dunedin, 9016

  • Auckland City Hospital

    Grafton, 1023

  • Waikato Hospital

    Hamilton, 3204

Other trials in New Zealand

Hungary4 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis Egyetem

    Budapest, 1082

  • Semmelweis Egyetem AOK

    Budapest, 1088

  • Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont

    Debrecen, 4025

Other trials in Hungary

Jordan4 sites

  • The Speciality Hospital (TSH) / Advanced Clinical Center

    Amman, 11194

  • Jordan University Hospital

    Amman, 11942

  • Irbid Specialty Hospital

    Aydoun, 21166

  • King Abdullah University Hospital

    Irbid, 22110

Other trials in Jordan

Slovakia4 sites

  • FNsP F.D.R. Banska Bystrica

    Banská Bystrica, 975 17

  • Cliniq s.r.o.

    Bratislava, 811 09

  • ENDOMED s.r.o

    Košice, 040 13

  • KM Management spol. s r.o.

    Nitra, 949 01

Other trials in Slovakia

Spain4 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. de La Marina Baixa

    Villajoyosa, 03570

  • Hosp. Univ. Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memorial Hospital

    Taipei, 10449

Other trials in Taiwan

Belgium3 sites

  • Onze -Lieve-Vrouwziekenhuis

    Aalst, 9300

  • CHU Saint-Pierre

    Brussels, 1000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Bulgaria3 sites

  • Medical centre Asklepion

    Sofia, 1606

  • DCC Convex EOOD

    Sofia, 1680

  • Medical Center Leo Clinic EOOD

    Targovishte, 7700

Other trials in Bulgaria

Canada3 sites

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • Fraser Clinical Trials Inc.

    New Westminster, British Columbia, V3L 3W4

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

Turkey (Türkiye)3 sites

  • Istanbul University

    Istanbul, 34098

  • Ege University Medical Faculty

    Izmir, 35040

  • Mersin University Medical Faculty

    Mersin, 33343

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

Being tested
Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3, Placebo
Keywords
Guselkumab, Colitis, Ulcerative
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • Guselkumab Dose 1Drug

    Guselkumab (Dose 1) will be administered as SC injection.

  • Guselkumab Dose 2Drug

    Guselkumab (Dose 2) will be administered as SC injection.

  • Guselkumab Dose 3Drug

    Guselkumab (Dose 3) will be administered as SC injection.

  • PlaceboOther

    Placebo will be administered as SC injection.

Study groups in NCT05528510
Study groupRoleWhat they receive
Group 1: GuselkumabExperimentalParticipants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2
Group 2: GuselkumabExperimentalParticipants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
Receives: Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 3
Group 3: PlaceboPlacebo comparatorParticipants will receive matching placebo SC injection.
Receives: Other: Placebo

What is being measured

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

  1. Percentage of Participants in Clinical Remission at Week 12

    Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

    Measured: Week 12

Secondary outcomes (8)

  1. Percentage of Participants in Symptomatic Remission at Week 12

    Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.

    Measured: Week 12

  2. Percentage of Participants With Endoscopic Improvement at Week 12

    Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

    Measured: Week 12

  3. Percentage of Participants in Clinical Response at Week 12

    Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.

    Measured: Week 12

  4. Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12

    Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

    Measured: Week 12

  5. Percentage of Participants in Clinical Remission at Week 24

    Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

    Measured: Week 24

  6. Percentage of Participants in Symptomatic Remission at Week 24

    Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity.

    Measured: Week 24

  7. Percentage of Participants With Endoscopic Improvement at Week 24

    Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

    Measured: Week 24

  8. Percentage of Participants in Clinical Response at Week 24

    Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by >= 30% and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity.

    Measured: Week 24

Timeline

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

  1. First posted6 Sep 2022
  2. Study start13 Sep 2022
  3. Primary completion2 Apr 2024
  4. Study completion6 Oct 2028 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05528510
Sponsor's protocol ID
CR109228
Other IDs
CNTO1959UCO3004, 2022-000365-41, 2023-504719-34-00, 2023
Acronym
ASTRO
Status last verified
Nov 2026
First submitted
19 Aug 2022
Last updated
4 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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

Publications

  • Long M, Allegretti JR, Danese S, Germinaro M, Baker T, Alvarez Y, Kavalam M, Han C, Jorgens S, Jiang L, Zhang H, Hisamatsu T, Rubin DT, Peyrin-Biroulet L; ASTRO Study Group. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Apr;11(4):284-298. doi: 10.1016/S2468-1253(25)00322-X. Epub 2026 Jan 13.

    PubMed 41544637

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab Dose 1, Guselkumab Dose 2 and Guselkumab Dose 3 in people with Colitis, Ulcerative, run by Janssen Research & Development, LLC at 236 sites in 25 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: under way, not looking for participants, as of the sponsor's last update on 4 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 236 sites in United States, Japan, China, Poland, Brazil and 20 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 9 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants in Clinical Remission at Week 12 (time frame: Week 12). 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 NCT05528510, which also lists 1 linked publication.

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 4 Nov 2026.

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