AzTrials
AzTrials

Crohn's DiseasePhase 3NCT03283085

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

A Phase 3 study testing 25 mg Ontamalimab and 75 mg Ontamalimab in people with Crohn's Disease and Ulcerative Colitis, run by Shire at 419 sites in 37 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or 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, Ulcerative Colitis
What is being tested?
25 mg Ontamalimab and 75 mg Ontamalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
557 participants
Where
419 sitesin 37 countries
Study dates
27 Feb 2018to 13 Dec 2023
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 with Ulcerative Colitis (UC):
  • 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 been enrolled previously in study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303, completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303 (NCT03290781), had responded to ontamalimab treatment (in the induction and/or maintenance studies), and meet one of the following criteria:
  • Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction studies and fulfilled the maintenance study response criteria, OR b. Participants have received ontamalimab at the maintenance study ET or Week 52 visit: i) Clinical composite score that has decreased by >or=2 points and >or=30%, with an accompanying decrease in the subscore for RB >or=1 point or a subscore for RB <or=1, compared to the baseline value for induction studies, and/or ii) Composite score that has decreased by >or=30% and >or=3 points compared to the baseline value for induction studies.
  • Participants receiving any treatment(s) for UC are eligible provided they have been on a stable dose for the designated period of time.
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  • Participants with Crohn's Disease:
  • 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 been enrolled previously in Study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307 (NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had responded to ontamalimab treatment (in the induction or maintenance studies) and meet one of the following criteria:
  • Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction study and fulfilled the maintenance study response criteria, OR
  • Participants have received ontamalimab at the maintenance study ET or Week 52 visit:
  • CDAI score that has decreased by >or=100 points at EOT visit compared to the baseline value for induction studies, and/or ii) SES-CD that has decreased by >or=25% compared to the baseline value for induction studies.
  • Participants receiving any treatment(s) for CD are eligible provided they have been on a stable dose for the designated period of time.

Who cannot join

  • Participants with UC:
  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-301, SHP647-302, or SHP647-303.
  • Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-301, SHP647-302, or SHP647-303.
  • Participants who are likely to require major surgery for UC.
  • Participants are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, 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 using appropriate contraception methods (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.
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  • Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
  • 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 [e.g.], renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [e.g. 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 study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have been advised to require treatment for latent or active disease, but 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 other investigational studies (other than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304.
  • Participants with Crohn's Disease:
  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305, SHP647-306 or SHP647-307.
  • Participants who permanently discontinued investigational product because of an adverse events (AE), regardless of relatedness to investigational product, in study SHP647-305, SHP647-306 or SHP647-307.
  • Participants who are likely to require major surgery for CD or developed acute severe complications of CD (with or without fulfilling the treatment failure criteria in the maintenance study) that required immediate intervention (e.g. need for immediate biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI) score more than (>) 450.
  • Participants are females who became pregnant during study SHP647-305, SHP647-306 or SHP647-307, 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 appropriate contraception methods (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.

Trial locations and contacts

419 sites in 37 countries.

419 sites in 37 countries

United States103 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • 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, LLC

    Chesterfield, Michigan, 48047

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Loretto Hospital

    Chicago, Illinois, 60644

  • Gastro Health Research

    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

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • IL Gastroenterology Group

    Gurnee, Illinois, 60041

  • 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

  • Biopharma Informatic 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

  • 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

  • Tibor Rubin VA Medical Center - NAVREF

    Long Beach, California, 90822

  • 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

  • Advanced Clinical Research Network

    Miami, Florida, 33174

  • 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

  • Infinite Clinical Trials

    Morrow, Georgia, 30260

  • United Medical Doctors

    Murrieta, California, 92563

  • 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

  • Bayside Clinical Research - New Port Richey

    New Port Richey, Florida, 34655

  • 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

  • Minnesota Gastroenterology PA

    Saint Paul, Minnesota, 55114

  • 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

  • Penn State Hershey Medical Group

    State College, Pennsylvania, 16803

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Arizona Digestive Health

    Sun City, Arizona, 85351

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • CHI Franciscan Digestive Care Associates

    Tacoma, Washington, 98405

  • DBC Research

    Tamarac, Florida, 33321

  • DM Clinical Research - ERN - PPDS

    Tomball, Texas, 77375

  • 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, 38237

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

    Webster, Texas, 77598

  • Winchester Gastroenterology Associates

    Winchester, Virginia, 22601-2872

  • 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

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 Bydgoszcz- PRATIA - PPDS

    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 NCM

    Nowa Sól, 67-100

  • Centrum Innowacyjnych Terapii

    Piaseczno, 05-500

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

    Poznan

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Endoskopia Sp. z o.o.

    Sopot, Pomeranian Voivodeship, 81-756

  • Twoja Przychodnia SCM

    Szczecin, West Pomeranian Voivodeship, 71-434

  • Sonomed Sp. z o.o.

    Szczecin, 70-361

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • H-T. Centrum Medyczne Endoterapia

    Tychy, 43-100

  • 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 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

Japan35 sites

  • Tokatsu Tsujinaka Hospital

    Abiko, 270-1166

  • Kunimoto Hospital

    Asahikawa, 070-0061

  • Shinbeppu Hospital

    Beppu, Ôita, 874-8538

  • 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, 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, 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 Tokushukai Hospital

    Sapporo, Hokkaidô, 004-0041

  • Sapporo Medical University Hospital

    Sapporo, Hokkaidô, 060-8543

  • Sapporo Higashi 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

  • Colo-Proctology Center Matsushima Clinic

    Yokohama, 220-0045

Other trials in Japan

Ukraine27 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

  • Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058

  • MNPE of Kharkiv Regional Council Regional Clinical Specialised 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

  • 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

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

    Kyiv, 02091

  • Medical Center of LLC Medical Center Dopomoga-Plus

    Kyiv, 02132

  • Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital

    Kyiv, 04073

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

    Kyiv, 04107

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

    Lviv, 79007

  • MNE Lviv Territorial Med Ass-n Multidisciplinary Clinical Hospital for Intensive Care and Ambulance

    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 VR

    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, Sankt-Peterburg, 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

    Smoensk, 214018

  • Stavropol State Medical University

    Stavropol, 355017

  • Regional Consulting and Diagnostics Centre

    Tyumen, 625026

Other trials in Russia

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

    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 (FG), 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

South Korea14 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

  • 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

  • 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

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

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, Sofia-Grad, 1784

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1000

  • 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 Convex EOOD

    Sofia, 1680

  • University Multiprofile Hospital for Active Treatment Sveta Anna

    Sofia, 1709

  • Diagnostic Consultative Centre Mladost - M OOD

    Varna, 9000

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

Romania12 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

  • SC Centrul Medical MEDICUM S.R.L.

    Bucharest, 031864

  • Emergency University Hospital

    Bucharest, 050098

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca, 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

Mexico11 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

  • 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. - PPDS

    Monterrey, Nuevo León, 64000

  • Accelerium, S. de R.L. de C.V.

    Monterrey, 64000

  • Centro de Investigacion Clinica Acelerada, S.C.

    Tepeyac Insurgentes, Mexico City, 07020

  • Clinical Research Institute

    Tlalnepantla, 54055

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

    Zapopan, Jalisco, 45030

Other trials in Mexico

Spain11 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 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, 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, 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

    Ústí nad Orlicí, 562 18

Other trials in Czechia

Greece6 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

  • Theageneio Anticancer Oncology Hospital of Thessaloniki

    Thessaloniki, 54007

  • Euromedica - PPDS

    Thessaloniki, 54645

Other trials in Greece

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

  • Amsterdam UMC - Meibergdreef 9

    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, 1500-650

  • Hospital de São Bernardo

    Setúbal, 2910-446

Other trials in Portugal

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

Belgium4 sites

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

  • UZ Leuven- Gasthuisberg Campus

    Leuven, Vlaams Brabant, 3000

  • CHU Mouscron

    Mouscron, 7700

Other trials in Belgium

Colombia4 sites

  • Servimed S.A.S

    Bucaramanga, Santander Department

  • Fundación Valle Del Lili

    Cali, Valle del Cauca Department, 760026

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

    Cali

  • Hospital Pablo Tobón Uribe

    Medellín, Antioquia, 050034

Other trials in Colombia

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

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

Estonia3 sites

  • East Viru Central Hospital

    Kohta-Järve, 31025

  • OÜ LV Venter

    Pärnu, Pärnumaa, 80010

  • West Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

Lebanon3 sites

  • Al Zahraa University Hospital

    Beirut

  • Rafik Hariri University Hospital

    Beirut

  • Hammoud Hospital University Medical Center

    Saida

Other trials in Lebanon

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

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, Dublin 4

Other trials in Ireland

Switzerland1 site

  • Universität Zürich

    Zurich, Zürich (de), 8091

Other trials in Switzerland

About this study

Official title: A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)

Being tested
25 mg Ontamalimab, 75 mg Ontamalimab
Keywords
Immunosuppressants, Mesalamine, Ulcerative Colitis, Crohn's disease, Gastroenteritis
Medical subject headings
Crohn Disease, Colitis, Ulcerative, Gastroenteritis

What participants receive

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

  • 25 mg OntamalimabDrug

    Also called PF-00547659, SHP647

    Ontamalimab SC solution for injection

  • 75 mg OntamalimabDrug

    Also called SHP647, PF-00547659

    Ontamalimab SC solution for injection

Study groups in NCT03283085
Study groupRoleWhat they receive
Ulcerative Colitis (UC): Ontamalimab 25 mgExperimentalParticipants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
Receives: Drug: 25 mg Ontamalimab
UC: Ontamalimab 25mg then 75 mgExperimentalParticipants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
Receives: Drug: 25 mg Ontamalimab; Drug: 75 mg Ontamalimab
UC: Ontamalimab 75 mgExperimentalParticipants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Receives: Drug: 75 mg Ontamalimab
Crohn's disease (CD): Ontamalimab 25 mgExperimentalParticipants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
Receives: Drug: 25 mg Ontamalimab
CD: Ontamalimab 25mg then 75 mgExperimentalParticipants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
Receives: Drug: 25 mg Ontamalimab; Drug: 75 mg Ontamalimab
CD: Ontamalimab 75 mgExperimentalParticipants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Receives: Drug: 75 mg Ontamalimab

What is being measured

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

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

    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.

    Measured: From first dose of study drug up to end of study [EOS] (up to 5.79 years)

  2. Number of Participants With Serious Infections

    Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator's assessment.

    Measured: From first dose of study drug up to EOS (up to 5.79 years)

  3. Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time

    Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported.

    Measured: From first dose of study drug up to EOS (up to 5.79 years)

  4. Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time

    ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported.

    Measured: From first dose of study drug up to EOS (up to 5.79 years)

  5. Number of Participants With Discernible Changes in Vital Signs Over Time

    Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported.

    Measured: From first dose of study drug up to EOS (up to 5.79 years)

Secondary outcomes (2)

  1. Number of Participants With Ulcerative Colitis With Treatment Response Over Time

    Treatment response over time was defined as clinical composite score that has decreased by greater than or equal to (≥2) points and ≥30 percentage (%), with an accompanying decrease in the sub score for rectal bleeding (RB) ≥1 point or a subscore for RB ≤ 1, and/or composite score that has decreased by ≥30% and ≥3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease. With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure.

    Measured: Up to 5.79 years

  2. Number of Participants With Crohn's Disease With Treatment Response Over Time

    Treatment response over time=Crohn's Disease Activity Index(CDAI)score that has decreased ≥100 points and/or simple endoscopic score for Crohn's disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence \& size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;>2cm=3);extent of ulcerated surface(none=0;<10%=1;10%-30%=2; >30%= 3);extent of affected surface(none=0;<50%=1;50%-75%=2;>75%=3);Presence \& type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3).

    Measured: Up to 5.79 years

Timeline

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

  1. First posted14 Sep 2017
  2. Study start27 Feb 2018
  3. Primary completion13 Dec 2023
  4. Study completion13 Dec 2023

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
557 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03283085
Sponsor's protocol ID
SHP647-304
Other IDs
2017-000574-11, 2017
Status last verified
May 2024
First submitted
12 Sep 2017
Last updated
21 Jun 2024
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 25 mg Ontamalimab and 75 mg Ontamalimab in people with Crohn's Disease and Ulcerative Colitis, run by Shire at 419 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 14 inclusion and 19 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 419 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. 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 21 Jun 2024). 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 Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug up to end of study [EOS] (up to 5.79 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03283085.

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 21 Jun 2024.

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