AzTrials
AzTrials

Ulcerative ColitisPhase 3FIGARO UC 303NCT03290781

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 study testing Ontamalimab in people with Ulcerative Colitis, run by Shire at 401 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 16 to 81 years
Conditions the study is for
Ulcerative Colitis
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
366 participants
Where
401 sitesin 37 countries
Study dates
4 Apr 2018to 1 Jul 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 81 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 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 legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
  • Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
  • Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:
  • A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
  • For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
  • Participants receiving any treatment(s) for ulcerative colitis (UC) 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 deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
  • Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
  • Participants who are likely to require surgery for UC during the study period.
  • Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study 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.
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  • 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 electrocardiogram (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 study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment.
  • 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 or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].

Trial locations and contacts

401 sites in 37 countries.

401 sites in 37 countries

United States94 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

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

    Baytown, Texas, 77521

  • 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

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • 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

  • Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS

    Columbus, Georgia, 31904

  • 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

  • Exemplar Research, Inc. - Elkins

    Elkins, West Virginia, 26241

  • United Medical Doctors

    Encinitas, California, 92024-1350

  • Medisphere Medical Research Center LLC

    Evansville, Indiana, 47714

  • Consultants For Clinical Research Inc

    Fairfield, Ohio, 45014

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • 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

  • IL Gastroenterology Group

    Gurnee, Illinois, 60031

  • National Clinical, LLC

    Hamtramck, Michigan, 48212

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky, 41701

  • Edward Hines Jr VA Hospital - NAVREF - PPDS

    Hines, Illinois, 60141

  • CroNOLA, LLC.

    Houma, Louisiana, 70360

  • Precision Research Institute, LLC

    Houston, Texas, 77039

  • Biopharma Informatic Inc.

    Houston, Texas, 77043

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Aztec Medical Research

    Houston, Texas, 77079

  • BI Research Center

    Houston, Texas, 77084

  • ENCORE Borland-Groover Clinical Research - ERN - PPDS

    Jacksonville, Florida, 32256

  • East Carolina Gastroenterology

    Jacksonville, North Carolina, 28546

  • SIH Research

    Kissimmee, Florida, 34741

  • University of California San Diego

    La Jolla, California, 92093

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601

  • NYU Langone Long Island Clinical Research Associates

    Lake Success, New York, 11042

  • 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

  • VA Long Beach Healthcare System - NAVREF - PPDS

    Long Beach, California, 90822

  • Ohio Clinical Research Partners LLC

    Mentor, Ohio, 44060

  • Arizona Digestive Health Mesa - East

    Mesa, Arizona, 85206

  • Hi Tech and Global Research, LLc

    Miami, Florida, 33135

  • Nuren Medical and Research Center

    Miami, Florida, 33144

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157

  • Crystal Biomedical Research

    Miami Lakes, Florida, 33065

  • Laporte County Institute For Clinical Research

    Michigan City, Indiana, 46360

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • United Medical Doctors

    Murrieta, California, 92563

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Pharma Research International Inc

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Weill Cornell Medical College

    New York, New York, 10021

  • Encompass Care

    North Las Vegas, Nevada, 89086

  • Dupage Medical Group

    Oakbrook Terrace, Illinois, 60181

  • Digestive Health Center PA

    Ocean Springs, Mississippi, 39564

  • Veteran's Research and Education Foundation - NAVREF - PPDS

    Oklahoma City, Oklahoma, 73104

  • 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

  • Veterans Research Foundation of Pittsburgh - NAVREF - PPDS

    Pittsburgh, Pennsylvania, 15240

  • BRCR Medical Center, Inc

    Plantation, Florida, 33322

  • 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

  • Southern Star Research Institute LLC

    San Antonio, Texas, 78229

  • University of California San Francisco

    San Francisco, California, 94158

  • Care Access Research, San Pablo

    San Pablo, California, 94806

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71103

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • St Louis Center For Clinical Research

    St Louis, Missouri, 63128

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • CHI Franciscan Digestive Care Associates

    Tacoma, Washington, 98405

  • DBC Research

    Tamarac, Florida, 33321

  • Bayside Clinical Research - New Port Richey

    Tampa, Florida, 33604

  • DM Clinical Research - ERN - PPDS

    Tomball, Texas, 77375

  • Advanced Gastroenterology-Union City

    Union City, Tennessee, 38237

  • Winchester Gastroenterology Associates

    Winchester, Virginia, 22601-2872

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Digestive Disease Associates

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland36 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 Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • 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

  • BioVirtus Centrum Medyczne

    Józefów, Masovian Voivodeship, 05-410

  • Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach

    Katowice, Silesian Voivodeship, 40-211

  • NZOZ All Medicus

    Katowice, 40-659

  • Krakowskie Centrum Medyczne

    Krakow, Lesser Poland Voivodeship, 31-501

  • Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska

    Krakow, 31-315

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

    Ksawerów, 95-054

  • Med Gastr Sp.z.o.o Sp.k

    Lodz, 91-034

  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny

    Lódz, Lódzkie, 90-302

  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

    Lódz, Lódzkie, 90-647

  • Instytut Centrum Zdrowia Matki Polki

    Lódz, Lódzkie, 93-338

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Centrum Innowacyjnych Terapii

    Piaseczno, 05-500

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

    Poznan, 60-856

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Endoskopia Sp. z o.o.

    Sopot, Pomeranian Voivodeship, 81-756

  • Twoja Przychodnia - Szczecińskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Bandurskiego 98/U12

    Szczecin, 71-685

  • 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

  • H-T. Centrum Medyczne Endoterapia

    Tychy, 43-100

  • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED

    Warsaw, Masovian Voivodeship, 03-580

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, Masovian Voivodeship, 04-749

  • Centrum Zdrowia MDM

    Warsaw, 00-635

  • Centrum Medyczne Warszawa - PRATIA - PPDS

    Warsaw, 01-868

  • Centralny Szpital Kliniczny MSW

    Warsaw, 02-507

  • 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

Japan34 sites

  • Tokatsu Tsujinaka Hospital

    Abiko, 270-1166

  • Kunimoto Hospital

    Asahikawa, 070-0061

  • Shinbeppu Hospital

    Beppu, Ôita, 874-0833

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Nihonbashi Egawa Clinic

    Chuo-Ku, Tokyo, 103-0028

  • Hakodate Koseiin Hakodate Goryoukaku Hospital

    Hakodate, 040-0001

  • Medical Corporation Aoyama Clinic

    Kobe, Hyôgo, 650-0015

  • Yuai Memorial Hospital

    Koga, 306-0232

  • Kawabe Clinic

    Koganei, 184-0003

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya, Saitama, 343-8555

  • Hidaka Coloproctology Clinic

    Kurume-shi, 839-0809

  • Aizawa Hospital

    Matsumoto-shi, 390-0814

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • 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, 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, Ôsaka, 533-0024

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • Sagamihara Kyodo Hospital

    Sagamihara, Kanagawa, 252-5188

  • Bellland General Hospital

    Sakai, 599-8247

  • 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

  • Tohoku Rosai Hospital

    Sendai, 981-8563

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293

  • Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital

    Takatsuki, 569-0086

  • Koukokukai Ebisu Clinic

    Tokyo, 150-0013

Other trials in Japan

Ukraine25 sites

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

    Chernivtsi, Chernivtsi Oblast, 58001

  • ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

    Dnipro, 49005

  • LLC Medical Center Family Medicine Clinic

    Dnipro, 49038

  • State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

    Dnipro, 49074

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

    Kharkiv, Kharkiv Oblast, 61037

  • Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine

    Kharkiv, 61039

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

    Kharkiv, 61058

  • MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

    Kharkiv, 61166

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

    Kherson, 73000

  • Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council

    Kryvyi Rih, 50056

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

    Kyiv, Kyïv, 04107

  • Medical Center of LLC Medical Clinic Blagomed

    Kyiv, 01023

  • Kyiv City Clinical Hospital #18

    Kyiv, 01030

  • Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"

    Kyiv, 01033

  • Municipal Institution of KRC Kyiv Regional Hospital #2

    Kyiv, 04073

  • Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway

    Lviv, 79007

  • Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

    Lviv, 79059

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

    Odesa, 65025

  • MNPE Central City Clinical Hospital of Uzhhorod City Council

    Uzhhorod, 88000

  • Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

    Vinnytsia, Vinnytsia Oblast, 21018

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsia, 21009

  • Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

    Vinnytsia, 21018

  • Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

    Vinnytsia, 21029

  • Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya, Zaporizhzhia Oblast, 69005

  • MNPE City Hospital No. 6 of Zaporizhzhia City Council

    Zaporizhzhya, 69035

Other trials in Ukraine

Russia18 sites

  • Kazan State Medical University

    Kazan', 420097

  • Moscow Clinical Scientific Center

    Moscow, 111123

  • Moscow Regional Research Clinical Institute Na Mfvladimirskiy

    Moscow, 129110

  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

    Nizhny Novgorod, 603126

  • Research Institute of Physiology and Basic Medicine

    Novosibirsk, 630117

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Rostov State Medical University

    Rostov-on-Don, 344091

  • St. Elizabeth Municipal Clinical Hospital

    Saint Petersburg, 195257

  • First St. Petersburg State Medical University n.a. I.P Pavlov

    Saint Petersburg, 197022

  • Union Clinic, LLC

    Saint Petersburg, 197110

  • 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

  • Medical Company Hepatolog, LLC

    Samara, 443063

  • SHI Regional Clinical Hospital

    Saratov, 410012

  • Smolensk Regional Clinical Hospital

    Smolensk, 214018

  • Stavropol State Medical University

    Stavropol, 355017

  • Regional Consulting and Diagnostics Centre

    Tyumen, 625026

Other trials in Russia

South Korea16 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, Daegu Gwang'yeogsi, 41944

  • Yeungnam University Hospital

    Daegu, 42415

  • Kyungpook National University Chilgok Hospital

    Daegu, 702-210

  • Gachon University Gil Medical Center

    Incheon, 21565

  • CHA Bundang Medical Center, CHA University

    Seongnam, Gyeonggido, 13496

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center PPDS

    Seoul, 06351

  • Inje University Seoul Paik Hospital

    Seoul, 100-032

  • 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

Italy15 sites

  • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

    Bologna, Emilia-Romagna, 40138

  • 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, 41124

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, Veneto, 37024

  • A.O.U. Maggiore della Carità

    Novara, 28100

  • Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino

    Padova, Veneto, 35128

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100

  • La Sapienza-Università di Roma-Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario A Gemelli

    Roma, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • Ospedale Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, Apulia, 71013

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128

Other trials in Italy

Bulgaria13 sites

  • University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Eurohospital

    Plovdiv, 4004

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS

    Rousse, 7002

  • Medical Center-1-Sevlievo EOOD

    Sevlievo, 5400

  • University Multiprofile Hospital for Active Treatment Sveta Anna

    Sofia, Sofia-Grad, 1750

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, Sofia-Grad, 1784

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1202

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1421

  • 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 Convex EOOD

    Sofia, 1680

  • Diagnostic Consultative Centre Mladost - M OOD

    Varna, 9020

Other trials in Bulgaria

Germany12 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

  • Asklepios Westklinikum Hamburg Ggmbh

    Hamburg, 22559

  • Universitatsklinikum Jena

    Jena, Thuringia, 07747

  • Universitatsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Klinikum rechts der Isa der Technischen Universitaet Muenchen

    Munich, 81675

  • Gastro Campus Research GbR

    Münster, North Rhine-Westphalia, 48159

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Hungary12 sites

  • Bekes Megyei Kozponti Korhaz

    Békéscsaba, 5600

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062

  • Pannónia Magánorvosi Centrum Kft

    Budapest, 1136

  • ENDOMEDIX Kft.

    Budapest, 1139

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bekes Megyei Kozponti Korhaz

    Gyula, 5700

  • Mohacsi Korhaz

    Mohács, 7700

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Tolna Megyei Balassa János Kórház

    Szekszárd, 7100

  • Csongrad Megyei Dr. Bugyi Istvan Korhaz

    Szentes, 6600

  • Jávorszky Ödön Kórház

    Vác, 2600

  • Csolnoky Ferenc Korhaz

    Veszprém, 8200

Other trials in Hungary

Romania11 sites

  • Dr.Carol Davila Emergency University Central Military Hospital

    Bucharest, 010825

  • Sana Monitoring SRL

    Bucharest, 011025

  • 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

  • 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

Mexico10 sites

  • Centro de Investigación Médica Aguascalientes

    Aguascalientes, 20116

  • Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlán Izcalli, 54769

  • 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, 64000

  • Clinical Research Institute

    Tlalnepantla, 54055

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

    Zapopan, 45030

Other trials in Mexico

Spain10 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 Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

Croatia8 sites

  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • Opca Bolnica Karlovac

    Karlovac, Karlovacka Županija, 47000

  • Clinical Hospital Centre Osijek

    Osijek, 31000

  • University Hospital Centre Split

    Split, 21000

  • General Hospital Virovitica

    Virovitica, 33000

  • General County Hospital Vukovar and Croatian Veterans Hospital

    Vukovar, 32000

  • General Hospital Zadar

    Zadar, 23 000

  • University Hospital Center Zagreb

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

United Kingdom8 sites

  • Aberdeen Royal Infirmary - PPDS

    Aberdeen, Aberdeen City, AB25 2ZN

  • Western General Hospital Edinburgh - PPDS

    Edinburh, EH4 2XU

  • Fairfield General Hospital - PPDS

    Lancashire, Bury, BL9 7TD

  • Whipps Cross University Hospital

    London, London, City of, E11 1NR

  • Royal Gwent Hospital - PPDS

    Newport, NP20 2UB

  • North Tyneside General Hospital

    North Shields, Northumberland, NE29 8NH

  • Royal Shrewsbury Hospital

    Shrewsbury, Shropshire, SY3 8XQ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • The Alfred Hospital

    Box Hill, Victoria, 3128

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • St Vincents Hospital Melbourne - PPDS

    Melbourne, Victoria, 3065

  • Mater Hospital Brisbane

    South Brisbane, Queensland, 4101

Other trials in Australia

Austria7 sites

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, Styria, 8036

  • Klinikum Klagenfurt Am Woerthersee

    Klagenfurt, 9020

  • Salzburger Landeskliniken

    Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Saint Pölten, 3100

  • A.ö. Krankenhaus der Barmherzigen Brüder

    Sankt Veit an der Glan, Carinthia, 9300

  • Medizinische Universitat Wien (Medical University of Vienna)

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Czechia6 sites

  • Hepato-Gastroenterologie HK, s. r. o.

    Hradec Králové, Hradec Králové Region, 500 12

  • PreventaMed s.r.o.

    Olomouc, Olomouc Region, 779 00

  • Institut Klinicke A Experimentalni Mediciny

    Prague, 140 21

  • ISCARE I.V.F. a.s.

    Prague, 170 00

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

    Ústí nad Labem, 401 13

  • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice

    Ústi Nad Orlici, 562 18

Other trials in Czechia

Israel6 sites

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120

  • Galilee Medical Center

    Nahariya, 22100

  • Nazareth EMMS Hospital

    Nazareth, 16100

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906

  • Baruch Padeh Poriya Medical Center

    Tiberias, 15208

Other trials in Israel

Netherlands5 sites

  • NWZ, location Alkmaar

    Alkmaar, North Holland, 1815 JD

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Academisch Medisch Centrum Amsterdam

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA

  • ETZ-Elisabeth

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Portugal5 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar do Algarve - Hospital de Portimao

    Faro, 8000-385

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

    Guimarães, 4835-044

  • Hospital da Luz

    Lisbon, Lisbon District, 1500-650

  • Hospital de São Bernardo

    Setúbal, 2910-446

Other trials in Portugal

Belgium4 sites

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • UZ Gasthuisberg

    Leuven, Vlaams Brabant, 3000

  • CHU Mouscron

    Mouscron, 7700

Other trials in Belgium

Greece4 sites

  • Ippokrateio General Hospital of Athens

    Athens, Attica, 11527

  • University General Hospital of Patras

    Pátrai, 26504

  • Theageneio Anticancer Oncology Hospital of Thessaloniki

    Thessaloniki, 54007

  • Euromedica - PPDS

    Thessaloniki, 54645

Other trials in Greece

New Zealand4 sites

  • Dunedin Hospital

    Dunedin, South Island, 9016

  • Auckland City Hospital

    Grafton, Auckland, 1023

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Newtown, Wellington Region, 6021

Other trials in New Zealand

Serbia4 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

Other trials in Serbia

Argentina3 sites

  • Fundación Favaloro

    Buenos Aires, C1093AAS

  • Hospital Privado Centro Médico de Córdoba

    Córdoba

  • Sanatorio 9 de Julio SA

    San Miguel de Tucumán

Other trials in Argentina

Colombia3 sites

  • Servimed S.A.S

    Bucaramanga, Santander Department

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

    Cali

  • Hospital Pablo Tobón Uribe

    Medellín, Antioquia, 050034

Other trials in Colombia

Estonia3 sites

  • East Viru Central Hospital

    Kohta-Järve, 31025

  • OÜ LV Venter

    Pärnu, 80010

  • West Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, LT- 08661

  • Vilnius City Clinical Hospital

    Vilnius, LT-10207

Other trials in Lithuania

Slovakia3 sites

  • Univerzitna nemocnica Bratislava

    Bratislava, 851 07

  • KM Management, spol. s r.o.

    Nitra, 949 01

  • Gastro LM, s.r.o.

    Prešov, 080 01

Other trials in Slovakia

South Africa3 sites

  • Dr JP Wright

    Claremont, Western Cape, 7708

  • CLINRESCO, ARWYP Medical Suites

    Johannesburg, Gauteng, 1619

  • Dr. J Breedt

    Pretoria, Gauteng, 0002

Other trials in South Africa

Canada2 sites

  • Toronto Digestive Disease Associates Inc

    Toronto, Ontario, M3N 2V7

  • Percuro Clinical Research LTD

    Victoria, British Columbia, V8P 2P5

Other trials in Canada

Lebanon2 sites

  • Rafik Hariri University Hospital

    Beirut

  • Hammoud Hospital University Medical Center

    Saida

Other trials in Lebanon

Turkey (Türkiye)2 sites

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Mersin University Medical Faculty

    Mersin, 33169

Other trials in Turkey (Türkiye)

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

Other trials in Ireland

Switzerland1 site

  • Universität Zürich

    Zurich, Zürich (de), 8091

Other trials in Switzerland

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 Ulcerative Colitis (FIGARO UC 303)

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Being tested
Ontamalimab, Placebo
Keywords
Ulcerative colitis
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • OntamalimabDrug

    Also called PF-00547659, SHP647

    Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).

  • PlaceboOther

    Participants will receive 1 mL of sterile aqueous buffered solution.

Study groups in NCT03290781
Study groupRoleWhat they receive
Ontamalimab 25 mgExperimentalParticipants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Receives: Drug: Ontamalimab
Ontamalimab 75 mgExperimentalParticipants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Receives: Drug: Ontamalimab
PlaceboPlacebo comparatorParticipants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
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 Remission Based on Composite Score at Week 52

    Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).

    Measured: At Week 52

Secondary outcomes (12)

  1. Number of Participants With Endoscopic Remission at Week 52

    Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).

    Measured: At Week 52

  2. Number of Participants With Clinical Remission at Week 52

    Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.

    Measured: At Week 52

  3. Number of Participants With Sustained Remission at Week 52

    Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).

    Measured: At Week 52

  4. Number of Participants With Clinical Response Based on Composite Score at Week 52

    Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood \& 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.

    Measured: At Week 52

  5. Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52

    Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.

    Measured: At Week 52

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

    Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood \& 3=blood alone passes).

    Measured: At Week 52

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

    Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.

    Measured: At Week 52

  8. Number of Participants With Remission Based on Total Mayo Score at Week 52

    Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration].

    Measured: At Week 52

  9. Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0

    Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.

    Measured: At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52

  10. Number of Participants With Sustained Endoscopic Remission at Week 52

    Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.

    Measured: At Week 52

  11. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.

    Measured: From start of study drug administration up to follow-up (Week 64)

  12. Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab

    Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.

    Measured: At Week 12, 24, 36 and 52

Timeline

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

  1. First posted25 Sep 2017
  2. Study start4 Apr 2018
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

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
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03290781
Sponsor's protocol ID
SHP647-303
Other IDs
2017-000573-37, 2017
Acronym
FIGARO UC 303
Status last verified
Dec 2021
First submitted
6 Sep 2017
Last updated
14 Jan 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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 Ulcerative Colitis, run by Shire at 401 sites in 37 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 401 sites in United States, Poland, Japan, Ukraine, Russia and 32 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 14 Jan 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 Remission Based on Composite Score at Week 52 (time frame: At Week 52). 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 NCT03290781, 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 14 Jan 2022.

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