AzTrials
AzTrials

Crohn's DiseasePhase 3CARMEN CD 307NCT03627091

Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

A Phase 3 study testing Ontamalimab in people with Crohn's Disease, run by Shire at 281 sites in 34 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD). Read more about this study

Who is it for?
Ages 16 to 80 years
Conditions the study is for
Crohn's Disease
What is being tested?
Ontamalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
281 sitesin 34 countries
Study dates
6 Feb 2019to 13 Sep 2021
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 16 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants and/or their parent or legally authorized representative (LAR) must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, to participate in the study.
  • Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:
  • Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or
  • Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline:
  • Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO sub scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the Bristol Stool Form Scale (BSFS) over the 7 most recent days*.
Show all 11Show fewer
  • A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.
  • A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.
  • A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO sub score of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*.
  • Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.
  • Participants receiving any treatments for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Who cannot join

  • Participants who had major protocol deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).
  • Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male participants) through the conclusion of study participation.
  • Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
  • Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
Show all 22Show fewer
  • Participants who have developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
  • Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
  • Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg,] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
  • Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.
  • Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrollment in Study SHP647-307.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN).
  • Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.
  • Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
  • Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).
  • White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).
  • Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)
  • Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.
  • Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
  • Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
  • Participants who are participating in other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.

Trial locations and contacts

281 sites in 34 countries.

281 sites in 34 countries

United States73 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Atlanta Gastroenterology Specialists, PC

    Atlanta, Georgia, 30308

  • Infinite Clinical Trials

    Atlanta, Georgia, 30349

  • HP Clinical Research

    Bountiful, Utah, 84010

  • Commonwealth Clinical Studies LLC

    Brockton, Massachusetts, 02302

  • New York Total Medical Care PC

    Brooklyn, New York, 11215

  • Renaissance Research Medical Group, INC

    Cape Coral, Florida, 33991

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Loretto Hospital

    Chicago, Illinois, 60644

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio, 45219

  • Consultants For Clinical Research Inc

    Cincinnati, Ohio, 45249

  • Gastro Florida

    Clearwater, Florida, 33756

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80903

  • Asthma and Allergy Associates PC - CRN - PPDS

    Colorado Springs, Colorado, 80907

  • Advanced Clinical Research Network

    Coral Gables, Florida, 33134

  • Alliance Medical Research LLC

    Coral Springs, Florida, 33071

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Northside Gastroenterology

    Cypress, Texas, 77429

  • Atlanta Center For Gastroenterology PC

    Decatur, Georgia, 30033

  • Mayo Clinic Health System - PPDS

    Duluth, Minnesota, 55805

  • Consultants For Clinical Research Inc

    Fairfield, Ohio, 45014

  • Mid Atlantic Health Specialists

    Galax, Virginia, 24333

  • Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

    Garland, Texas, 75044

  • Gastro One

    Germantown, Tennessee, 38138

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • IL Gastroenterology Group

    Gurnee, Illinois, 60031

  • National Clinical, LLC

    Hamtramck, Michigan, 48212

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky, 41701

  • CroNOLA, LLC.

    Houma, Louisiana, 70360

  • Precision Research Institute, LLC

    Houston, Texas, 77039

  • Biopharma Informatic Inc.

    Houston, Texas, 77043

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • BI Research Center

    Houston, Texas, 77084

  • SIH Research

    Kissimmee, Florida, 34741

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • OM Research LLC - Lancaster - ClinEdge - PPDS

    Lancaster, California, 93534

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Atria Clinical Research - Clinedge - PPDS

    Little Rock, Arkansas, 72209

  • Arizona Digestive Health Mesa - East

    Mesa, Arizona, 85206

  • Hi Tech and Global Research, LLc

    Miami, Florida, 33135

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157

  • Crystal Biomedical Research

    Miami Lakes, Florida, 33065

  • Laporte County Institute For Clinical Research

    Michigan City, Indiana, 46360

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Pharma Research International Inc

    Naples, Florida, 34110

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • DelRicht Clinical Research, LLC - ClinEdge - PPDS

    New Orleans, Louisiana, 70115

  • Encompass Care

    North Las Vegas, Nevada, 89086

  • Southtowns Gastroenterology, PLLC

    Orchard Park, New York, 14127

  • Omega Research Consultants LLC - Clinedge - PPDS

    Orlando, Florida, 32810

  • Elite Clinical Studies - Phoenix - Clinedge - PPDS

    Phoenix, Arizona, 85018

  • Accel Research Sites - St. Petersburg - ERN - PPDS

    Pinellas Park, Florida, 33781

  • Alliance Clinical Research-(Vestavia Hills)

    Poway, California, 92064

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • East Coast Institute for Research, LLC

    Saint Augustine, Florida, 32086

  • Minnesota Gastroenterology PA

    Saint Paul, Minnesota, 55114

  • Southern Star Research Institute LLC

    San Antonio, Texas, 78229

  • Care Access Research, San Pablo

    San Pablo, California, 94806

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71103

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Penn State Hershey Medical Group

    State College, Pennsylvania, 16803

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • DBC Research

    Tamarac, Florida, 33321

  • Bayside Clinical Research - New Port Richey

    Tampa, Florida, 33604

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • CATS Research Center - University of Arizona

    Tucson, Arizona, 85724

  • Advanced Gastroenterology-Union City

    Union City, Tennessee, 38261

  • Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS

    Webster, Texas, 77598

  • Winchester Gastroenterology Associates

    Winchester, Massachusetts, 22601

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan, 49519

  • Digestive Disease Associates

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland29 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

  • Vitamed Galaj i Cichomski sp.j.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Medyczne Czestochowa - PRATIA - PPDS

    Częstochowa, 42-200

  • Centrum Medyczne Gdynia - PRATIA - PPDS

    Gdynia, 81-338

  • Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii

    Gmina Końskie, Świętokrzyskie Voivodeship, 26-200

  • NZOZ All Medicus

    Katowice, 40-660

  • Med Gastr Sp.z.o.o Sp.k

    Lodz, 91-034

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

    Lódz, Lódzkie, 90-302

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

    Lódz, Lódzkie, 90-647

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa

    Poznan, 60-848

  • Centrum Medyczne Warszawa - PRATIA - PPDS

    Rzeszów, 35-068

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Endoskopia Sp. z o.o.

    Sopot, Pomeranian Voivodeship, 81-756

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warsaw, Masovian Voivodeship, 02-781

  • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

    Warsaw, Masovian Voivodeship, 03-580

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, Masovian Voivodeship, 04-749

  • Centrum Zdrowia M D M

    Warsaw, 00-635

  • Centralny Szpital Kliniczny MSW

    Warsaw, 02-507

  • BioVirtus Centrum Medyczne

    Warsaw, 02-797

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

  • Melita Medical

    Wroclaw, Lower Silesian Voivodeship, 50-449

  • Lexmedica

    Wroclaw, Lower Silesian Voivodeship, 53-114

  • Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II

    Zamość, 22-400

Other trials in Poland

Japan21 sites

  • Kunimoto Hospital

    Asahikawa, 070-0061

  • Medical Corporation Aoyama Clinic

    Kobe, Hyôgo, 650-0015

  • Hidaka Coloproctology Clinic

    Kurume-shi, 839-0809

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Nishinomiya Municipal Central Hospital

    Nishinomiya, 663-8014

  • Hyogo College of Medicine

    Nishinomiya-shi, Hyôgo, 663-8501

  • Ishida Clinic of IBD and Gastroenterology

    Ōita, Ôita, 870-0823

  • Ome Municipal General Hospital

    Ōme, Tokyo, 198-0042

  • Onomichi General Hospital

    Onomichi

  • Chiinkai Dojima General & Gastroenterology Clinic

    Osaka, 530-0003

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • Yodogawa Christian Hospital

    Osaka, 533-0024

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô, 060-8543

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Sapporo Tokushukai Hospital

    Sapporo, 065-0033

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293

  • Nihonbashi Egawa Clinic

    Tokyo, 103-0028

  • Colo-Proctology Center Matsushima Clinic

    Yokohama, 220-0045

Other trials in Japan

Ukraine13 sites

  • Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

    Chernivtsi, Chernivtsi Oblast, 58001

  • LLC Medical Center Family Medicine Clinic

    Dnipro, 49038

  • Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council

    Kharkiv, Kharkiv Oblast, 61037

  • Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058

  • Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

    Kherson, 73000

  • Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, Kyïv, 04107

  • Medical Center of LLC Medical Clinic Blagomed

    Kyiv, 01023

  • Medical Center OK!Clinic+LLC International Institute of Clinical Research

    Kyiv, 02091

  • Medical Center of LLC Medical Center Dopomoga-Plus

    Kyiv, 02132

  • Municipal Institution of KRC Kyiv Regional Hospital #2

    Kyiv, 04073

  • Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

    Lviv, 79059

  • Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

    Vinnytsia, 21029

  • MNPE City Hospital No. 6 of Zaporizhzhia City Council

    Zaporizhzhya, 69035

Other trials in Ukraine

Romania12 sites

  • Sana Monitoring SRL

    Bucharest, Bucharest, 011025

  • Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest, 010825

  • Colentina Clinical Hospital

    Bucharest, 020125

  • Prof. Dr. Matei Bals Institute of Infectious Diseases

    Bucharest, 021105

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Centrul Medical Hifu Terramed Conformal S.R.L.

    Bucharest, 031864

  • Emergency University Hospital

    Bucharest, 050098

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca, Cluj, 400006

  • Affidea Romania SRL

    Constanța, RO-900591

  • Gastromedica SRL

    Iași, 700506

  • Dr. Tirnaveanu Amelita Private Practice

    Oradea, 410066

  • Dr. Goldis Gastroenterology Center SRL

    Timișoara, 300002

Other trials in Romania

Italy11 sites

  • Azienda Ospedaliera Mater Domini Di Catanzaro

    Catanzaro, Calabria, 88100

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

  • Azienda Ospedaliero Universitaria Di Modena Policlinico

    Modena, Emilia-Romagna, 41100

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

  • A.O.U. Maggiore della Carità

    Novara, 28100

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100

  • La Sapienza-Università di Roma-Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

South Korea11 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Kyungpook National University Chilgok Hospital

    Daegu, 702-210

  • Gachon University Gil Medical Center

    Incheon, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam, Gyeonggido, 13496

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Inje University Seoul Paik Hospital

    Seoul, 04551

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

    Suwon, Gyeonggido, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gang'weondo, 26426

Other trials in South Korea

Germany10 sites

  • Universitätsklinikum der RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Gastroenterologische Facharztpraxis am Mexikoplatz

    Berlin-Zehlendorf, 14163

  • Sana Klinikum Biberach

    Biberach an der Riss, 88400

  • Uniklinik Köln

    Cologne, North Rhine-Westphalia, 50937

  • Universitätsklinikum Frankfurt

    Frankfurt, 60596

  • Universitatsklinikum Jena

    Jena, Thuringia, 07747

  • Universitatsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Klinikum rechts der Isa der Technischen Universitaet Muenchen

    Munich, Bavaria, 81675

  • Gastro Campus Research GbR

    Münster, North Rhine-Westphalia, 48159

Other trials in Germany

Bulgaria9 sites

  • Multiprofile Hospital for Active Treatment Eurohospital

    Plovdiv, 4004

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, Sofia-Grad, 1784

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1202

  • Diagnostic and Consulting Center Aleksandrovska EOOD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1632

  • Medical Center Convex EOOD

    Sofia, 1680

  • Diagnostic Consultative Centre Mladost - M OOD

    Varna, 9000

Other trials in Bulgaria

Spain9 sites

  • Centro Medico Teknon - Grupo Quironsalud

    Barcelona, 08022

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, Córdoba, 14004

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital General Universitario Gregorio Maranon

    Madrid, Madrid, Communidad Delaware, 28007

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

Hungary8 sites

  • Bekes Megyei Kozponti Korhaz

    Békéscsaba, 5600

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062

  • Pannónia Magánorvosi Centrum Kft

    Budapest, 1135

  • ENDOMEDIX Kft.

    Budapest, 1139

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Mohacsi Korhaz

    Mohács, 7700

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Tolna Megyei Balassa János Kórház

    Szekszárd, 7100

Other trials in Hungary

Mexico7 sites

  • Clinica de Higado y Gastroenterologia Integral, S.C.

    Cuernavaca, Morelos, 62170

  • JM Research S.C

    Cuernavaca, Morelos, 62290

  • Centro de Investigacion Clinica Acelerada, S.C.

    Distrito Federal, 07020

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

    Durango, 34000

  • Unidad de Atencion Medica e Investigacion en Salud

    Mérida, Yucatán, 97000

  • Accelerium, S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Zapopan, Jalisco, 45030

Other trials in Mexico

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincents Hospital Melbourne - PPDS

    Fitzroy, Victoria, 3065

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

Russia6 sites

  • Rostov State Medical University

    Rostov-on-Don, 344091

  • St. Elizabeth Municipal Clinical Hospital

    Saint Petersburg, 195067

  • Russian Medical Military Academy n.a. S.M. Kirov

    Saint Petersburg

  • Medical University Reaviz

    Samara, 443011

  • Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city

    Samara, 443029

  • SHI Regional Clinical Hospital

    Saratov, 410012

Other trials in Russia

Greece5 sites

  • Ippokrateio General Hospital of Athens

    Athens, Attica, 11527

  • University General Hospital of Heraklion

    Heraklion, 71110

  • Iatriko Palaiou Falirou

    Paliao Faliro, 17562

  • University General Hospital of Patras

    Pátrai, 26504

  • Euromedica - PPDS

    Thessaloniki, 54645

Other trials in Greece

Serbia5 sites

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • University Clinical Center Kragujevac

    Kragujevac, Šumadijski Okrug, 34000

  • University Clinical Center Nis

    Niš, 18000

  • General Hospital Vrsac

    Vršac, 26300

  • Clinical Hospital Center Zemun

    Zemun

Other trials in Serbia

Austria4 sites

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, Styria, 8036

  • Salzburger Landeskliniken

    Salzburg, 5020

  • Klinikum Wels-Grieskirchen GmbH

    Vienna, State of Vienna, A-1090

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Academisch Medisch Centrum Amsterdam

    Bonheiden, Antwerpen, 2820

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • CHU Mouscron

    Mouscron, 7700

Other trials in Belgium

Croatia4 sites

  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • General Hospital Virovitica

    Virovitica, 33000

  • University Hospital Center Zagreb

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Israel4 sites

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120

  • Galilee Medical Center

    Nahariya, 22100

  • Baruch Padeh Poriya Medical Center

    Tiberias, 15208

Other trials in Israel

United Kingdom4 sites

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, AB25 2ZN

  • Royal Gwent Hospital - PPDS

    Newport, NP20 2UB

  • North Tyneside General Hospital

    North Shields, Northumberland, NE29 8NH

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

New Zealand3 sites

  • Dunedin Hospital

    Dunedin, South Island, 9016

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Portugal3 sites

  • Hospital Senhora da Oliveira - Guimaraes, E.P.E

    Guimarães, 4835-044

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Portimão, 8500-338

Other trials in Portugal

South Africa3 sites

  • Dr JP Wright

    Claremont, Western Cape, 7708

  • CLINRESCO, ARWYP Medical Suites

    Johannesburg, Gauteng, 1619

  • Dr. J Breedt

    Pretoria, Gauteng, 0084

Other trials in South Africa

Argentina2 sites

  • Fundación Favaloro

    Buenos Aires, C1093AAS

  • Hospital Privado Centro Médico de Córdoba

    Córdoba

Other trials in Argentina

Colombia2 sites

  • Fundación Valle Del Lili

    Cali, Valle del Cauca Department, 760026

  • IPS Centro Médico Julián Coronel S.A.S. - PPDS

    Cali

Other trials in Colombia

Estonia2 sites

  • OÜ LV Venter

    Pärnu, 80010

  • West Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

Lebanon2 sites

  • Al Zahraa University Hospital

    Beirut

  • Hammoud Hospital University Medical Center

    Saida

Other trials in Lebanon

Lithuania2 sites

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT- 08661

  • Vilnius City Clinical Hospital

    Vilnius, LT-10207

Other trials in Lithuania

Netherlands2 sites

  • NWZ, location Alkmaar

    Den Helder, North Holland, 1782 GZ

  • ETZ-Elisabeth

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Slovakia2 sites

  • KM Management, spol. s r.o.

    Nitra, 949 01

  • Gastro LM, s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Bosnia and Herzegovina1 site

  • Clinical Center Banja Luka

    Banja Luka, 78000

Other trials in Bosnia and Herzegovina

Ireland1 site

  • St Vincent's University Hospital

    Dublin, 4

Other trials in Ireland

Turkey (Türkiye)1 site

  • Mersin University Medical Faculty

    Mersin, 33169

Other trials in Turkey (Türkiye)

About this study

Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Conditions
Crohn's Disease
Being tested
Ontamalimab, Placebo
Keywords
Crohn's disease
Medical subject headings
Crohn Disease

What participants receive

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

  • OntamalimabDrug

    Also called SHP647, PF-00547659

    SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.

  • PlaceboOther

    SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.

Study groups in NCT03627091
Study groupRoleWhat they receive
Ontamalimab 25 mgExperimentalParticipants will receive 25 mg of ontamalimab subcutaneous (SC) injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
Receives: Drug: Ontamalimab
Ontamalimab 75 mgExperimentalParticipants will receive 75 mg of ontamalimab SC injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
Receives: Drug: Ontamalimab
PlaceboPlacebo comparatorParticipants will receive placebo matched with ontamalimab SC injection using prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
Receives: Other: Placebo

What is being measured

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

  1. Number of Participants With Clinical Remission at Week 52

    Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point numerical rating scale [NRS] ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or discontinuation before Week 52 were considered failures. Number of participants with clinical remission at Week 52 were reported.

    Measured: At Week 52

  2. Number of Participants With Enhanced Endoscopic Response at Week 52

    Enhanced endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 50 percent (%) from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823] baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non responders. Number of participants with enhanced endoscopic response at Week 52 were reported.

    Measured: At Week 52

Secondary outcomes (7)

  1. Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52

    Clinical remission was defined as a CDAI score of <150. CDAI assessed CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective). CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, >451 points: severely active to fulminant disease. Higher score indicating more severity. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission as measured by CDAI at Week 52 were reported.

    Measured: At Week 52

  2. Number of Participants With Glucocorticoid-free Clinical Remission at Week 52

    Glucocorticoid-free clinical remission defined as clinical remission by 2-item PRO not requiring any treatment with glucocorticoids for at least 12 weeks prior to Week 52 visit. Clinical remission defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency<=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were non-responders. Number of participants with glucocorticoid-free clinical remission response at Week 52 were reported.

    Measured: At Week 52

  3. Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52

    Clinical remission was defined by CD daily e-diary 2-item PRO subscores of average daily abdominal pain <=1 (based on the 4 point scale, with scores ranging from 0 [none] to 3 [severe]) over the 7 most recent days and average daily stool frequency <=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with clinical remission based on Crohn's Disease (CD) e-diary Sub-scores for abdominal pain was was reported.

    Measured: At Week 52

  4. Number of Participants With Sustained Clinical Remission at Week 52

    Sustained clinical remission was defined as clinical remission by 2-item PRO at both Week 52 visit and the maintenance baseline in this Study. Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days. BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid). Number of participants with sustained clinical remission at Week 52 were reported.

    Measured: At Week 52

  5. Number of Participants With Sustained Enhanced Endoscopic Response at Week 52

    Sustained enhanced endoscopic response was defined as enhanced endoscopic response at both Week 52 visit and the maintenance baseline in this study. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50 % from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Number of participants with sustained enhanced endoscopic response at Week 52 were reported.

    Measured: At Week 52

  6. Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52

    Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency <= 2 of Type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50% from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline. Participants with missing data at Week 52 or who discontinued before Week 52 were considered non-responders.

    Measured: At Week 52

  7. Number of Participants With Complete Endoscopic Healing at Week 52

    Complete endoscopic healing was defined as SES-CD scale score from 0-2. The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing. Each graded from 0-3. Scale ranges from 0-56 with a higher score indicating greater severity of disease. Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures. Number of participants with complete endoscopic healing at Week 52 were reported.

    Measured: At Week 52

Timeline

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

  1. First posted13 Aug 2018
  2. Study start6 Feb 2019
  3. Primary completion21 Jun 2021
  4. Study completion13 Sep 2021

Why it stopped: Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03627091
Sponsor's protocol ID
SHP647-307
Other IDs
2017-000617-23, 2017
Acronym
CARMEN CD 307
Status last verified
Mar 2022
First submitted
24 Jul 2018
Last updated
31 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Vermeire S, Danese S, Sandborn WJ, Schreiber S, Hanauer S, D'Haens G, Nagy P, Thakur M, Bliss C, Cataldi F, Goetsch M, Gorelick KJ, Reinisch W. Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease. J Crohns Colitis. 2024 May 31;18(5):708-719. doi: 10.1093/ecco-jcc/jjad199.

    PubMed 38096402

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ontamalimab in people with Crohn's Disease, run by Shire at 281 sites in 34 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 11 inclusion and 22 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: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 281 sites in United States, Poland, Japan, Ukraine, Romania and 29 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 31 Mar 2022). 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?

Number of Participants With Clinical Remission at Week 52 (time frame: At Week 52). The study lists 2 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 NCT03627091, 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 31 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in