Study Stopped
Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
FIGARO UC 301
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)
2 other identifiers
interventional
380
17 countries
200
Brief Summary
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2018
Typical duration for phase_3
200 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedStudy Start
First participant enrolled
February 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2020
CompletedResults Posted
Study results publicly available
May 7, 2021
CompletedJune 14, 2021
June 1, 2021
2.4 years
August 21, 2017
April 12, 2021
June 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Remission at Week 12
Remission was defined as a composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy as stool frequency sub-score of 0 or 1 with at least a 1-point change from baseline, rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excluded friability). The composite score was a recommended measure consisted of the Mayo score without the physician global assessment (PGA) sub-score and ranged from 0 to 9 points. The Mayo score was a measure of Ulcerative Colitis (UC) disease activity. It ranged from 0 to 12 points and consisted of 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease. The sub-scores were stool frequency (0-3); rectal bleeding (0-3); findings of endoscopy (0-3); PGA (0-3).
At Week 12
Secondary Outcomes (23)
Number of Participants With Endoscopic Remission at Week 12
At Week 12
Number of Participants With Clinical Remission at Week 12
At Week 12
Number of Participants With Clinical Response Based on Composite Score at Week 12
At Week 12
Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12
At Week 12
Number of Participants With Remission Based on Total Mayo Score at Week 12
At Week 12
- +18 more secondary outcomes
Study Arms (3)
Ontamalimab 25 mg
EXPERIMENTALParticipants will receive 25 milligrams (mg) of ontamalimab (SHP647) subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.
Ontamalimab 75 mg
EXPERIMENTALParticipants will receive 75 mg of ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.
Interventions
Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).
Eligibility Criteria
You may qualify if:
- 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 informed consent and/or assent, as applicable, to participate in the study.
- Participants must be between greater than or equal to (\>=)16 and \<=80 years of age at the time of the signing of the informed consent/assent form.
- Participants less than (\<) 18 years of age must weigh \>=40 kg and must have body mass index (BMI) \>=16.5 kilogram per square meter (kg/m\^2).
- Participants must have a documented diagnosis of UC for \>=3 months before screening. The following must be available in each participant's source documentation:
- A biopsy report to confirm the histological diagnosis.
- A report documenting disease duration based upon prior colonoscopy. Note: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
- Participants must have moderate to severe active UC, defined as a total Mayo score of \>=6, including a centrally read endoscopic subscore \>=2, rectal bleeding subscore \>=1, and stool frequency subscore \>=1 at baseline.
- Participants must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
- Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate \[ASA\]), glucocorticoids, immunosuppressants (azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], or methotrexate \[MTX\]), or anti-tumor necrosis factor (TNF).
- Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
- Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential.
You may not qualify if:
- \- Participants with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease.
- Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
- Participants with past medical history or presence of toxic megacolon.
- Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
- Participants at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit, unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.
- Participants at risk for colorectal cancer include, but are not limited to:
- Participants with extensive colitis for \>=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>=10 years before screening, regardless of age.
- Participants \>=50 years of age at the time of signing of the informed consent form.
- \- Participants have had prior treatment with SHP647.
- \- Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
- \- Participants have received anti-TNF treatment within 60 days before baseline.
- \- Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline.
- \- Participants have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline.
- \- Participants have ever received anti-integrin/adhesion molecule treatment (example (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).
- \- Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.
- +45 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (207)
Atria Clinical Research - Clinedge - PPDS
Little Rock, Arkansas, 72209, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, 93534, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80906, United States
Asthma and Allergy Associates PC - CRN - PPDS
Colorado Springs, Colorado, 80907, United States
Advanced Clinical Research Network
Coral Gables, Florida, 33134, United States
Nuren Medical and Research Center
Miami, Florida, 33144, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Omega Research Consultants LLC - Clinedge - PPDS
Orlando, Florida, 32810, United States
East Coast Institute for Research, LLC
Saint Augustine, Florida, 32086, United States
Gastrointestinal Diseases, Inc. Research
Columbus, Georgia, 31904, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Medisphere Medical Research Center LLC
Evansville, Indiana, 47714, United States
Laporte County Institute For Clinical Research
Michigan City, Indiana, 46360, United States
Clinical Trials of SWLA LLC
Lake Charles, Louisiana, 70601, United States
Louisiana Research Center LLC
Shreveport, Louisiana, 71105, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Digestive Health Center PA
Ocean Springs, Mississippi, 39564, United States
New York Total Medical Care PC
Brooklyn, New York, 11215, United States
Piedmont Healthcare
Statesville, North Carolina, 28677, United States
Consultants For Clinical Research Inc
Cincinnati, Ohio, 45219, United States
Consultants For Clinical Research Inc
Cincinnati, Ohio, 45249, United States
Consultants For Clinical Research Inc
Fairfield, Ohio, 45014, United States
Allegheny Center For Digestive Health
Pittsburgh, Pennsylvania, 15212, United States
Digestive Disease Associates
Wyomissing, Pennsylvania, 19610, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Advanced Gastroenterology-Union City
Union City, Tennessee, 38261, United States
Inquest Clinical Research/Coastal Gastroenterology Associates, PA
Baytown, Texas, 77521, United States
Northside Gastroenterology
Cypress, Texas, 77429, United States
DM Clinical Research - ERN - PPDS
Tomball, Texas, 77375, United States
HP Clinical Research
Bountiful, Utah, 84010, United States
Digestive Health Center at UWMC
Seattle, Washington, 98195, United States
University of Washington
Seattle, Washington, 98195, United States
CHI Franciscan Digestive Care Associates
Tacoma, Washington, 98405, United States
Exemplar Research, Inc. - Elkins
Elkins, West Virginia, 26241, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, 3065, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
A.ö. Krankenhaus der Barmherzigen Brüder
Sankt Veit an der Glan, Carinthia, 9300, Austria
LKH-Universitätsklinikum Klinikum Graz
Graz, Styria, 8036, Austria
Klinikum Klagenfurt Am Woerthersee
Klagenfurt, 9020, Austria
Salzburger Landeskliniken
Salzburg, 5020, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100, Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Instituto Goiano de Gastroenterologia E Endoscopia Digestiva Ltda
Goiânia, Goiás, 74535-170, Brazil
Hospital Da Cidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
Santo André, São Paulo, 09190-510, Brazil
University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000, Croatia
Opca Bolnica Karlovac
Karlovac, Karlovacka Županija, 47000, Croatia
Opca bolnica Bjelovar
Bjelovar, 43000, Croatia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
University Hospital Centre Split
Split, 21000, Croatia
General Hospital Virovitica
Virovitica, 33000, Croatia
General County Hospital Vukovar and Croatian Veterans Hospital
Vukovar, 32000, Croatia
General Hospital Zadar
Zadar, 23 000, Croatia
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové, Královéhradecký kraj, 500 12, Czechia
PreventaMed s.r.o.
Olomouc, Olomoucký kraj, 779 00, Czechia
Institut Klinicke A Experimentalni Mediciny
Prague, 140 21, Czechia
ISCARE I.V.F. a.s.
Prague, 170 04, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 401 13, Czechia
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice
Ústí nad Orlicí, 562 18, Czechia
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum der RWTH Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Gastro Campus Research GbR
Münster, North Rhine-Westphalia, 48159, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Gastroenterologische Facharztpraxis am Mexikoplatz
Berlin-Zehlendorf, 14163, Germany
Sana Klinikum Biberach
Biberach an der Riss, 88400, Germany
Uniklinik Köln
Cologne, 50937, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60590, Germany
Asklepios Westklinikum Hamburg Ggmbh
Hamburg, 22559, Germany
Klinikum rechts der Isa der Technischen Universitaet Muenchen
Munich, 81675, Germany
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center - PPDS
Jerusalem, 91120, Israel
Galilee Medical Center
Nahariya, 22100, Israel
Nazareth EMMS Hospital
Nazareth, 16100, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 6423906, Israel
Baruch Padeh Poriya Medical Center
Tiberias, 15208, Israel
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo (FG), Apulia, 71013, Italy
Azienda Ospedaliera Mater Domini Di Catanzaro
Catanzaro, Calabria, 88100, Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, Emilia-Romagna, 41124, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00152, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, 37024, Italy
Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino - INCIPIT - PIN
Padua, Veneto, 35128, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, 40138, Italy
A.O.U. Maggiore della Carità
Novara, 28100, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100, Italy
La Sapienza-Università di Roma-Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario A Gemelli
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128, Italy
Sapporo Tokushukai Hospital
Sapporo, Hokkaidô, 004-0041, Japan
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, 252-5188, Japan
Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
Ome Municipal General Hospital
Ōme, Tokyo, 198-0042, Japan
Tokatsu Tsujinaka Hospital
Abiko-shi, Chiba, 270-1168, Japan
Hakodate Koseiin Hakodate Goryoukaku Hospital
Hakodate, 040-0001, Japan
Yuai Memorial Hospital
Koga, 306-0232, Japan
Kawabe Clinic
Koganei, 184-0003, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, 343-8555, Japan
Hidaka Coloproctology Clinic
Kurume-shi, 839-0809, Japan
Aichi Medical University Hospital
Nagakute, 480-1195, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya, 663-8014, Japan
Onomichi General Hospital
Onomichi, Japan
Shiga University of Medical Science Hospital
Ōtsu, 520-2192, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
Shinbeppu Hospital
Beppu, Ôita, 874-0833, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, LT- 08661, Lithuania
Vilnius City Clinical Hospital
Vilnius, LT-10207, Lithuania
ETZ-Elisabeth
Tilburg, North Brabant, 5022 GC, Netherlands
NWZ, location Alkmaar
Alkmaar, North Holland, 1815 JD, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA, Netherlands
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Academisch Medisch Centrum Amsterdam
Amsterdam, 1105 AZ, Netherlands
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland
Krakowskie Centrum Medyczne
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449, Poland
Lexmedica
Wroclaw, Lower Silesian Voivodeship, 53-114, Poland
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
Lódz, Lódzkie, 90-302, Poland
SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej UM w Lodzi
Lódz, Lódzkie, 90-647, Poland
Instytut Centrum Zdrowia Matki Polki
Lódz, Lódzkie, 93-338, Poland
Centrum Medyczne Warszawa - PRATIA - PPDS
Warsaw, Masovian Voivodeship, 01-868, Poland
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
Warsaw, Masovian Voivodeship, 03-580, Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, Masovian Voivodeship, 04-749, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Endoskopia Sp. z o.o.
Sopot, Pomeranian Voivodeship, 81-756, Poland
H-T. Centrum Medyczne Endoterapia
Tychy, Silesian Voivodeship, 43-100, Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796, Poland
Centrum Medyczne Czestochowa - PRATIA - PPDS
Częstochowa, 42-200, Poland
Centrum Medyczne Gdynia - PRATIA - PPDS
Gdynia, 81-338, Poland
BioVirtus Centrum Medyczne
Józefów, 05-410, Poland
Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach
Katowice, 40-211, Poland
NZOZ All Medicus
Katowice, 40-659, Poland
Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska
Krakow, 31-315, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054, Poland
Med Gastr Sp.z.o.o Sp.k
Lodz, 91-034, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
Centrum Innowacyjnych Terapii
Piaseczno, 05-500, Poland
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
Poznan, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Zamość, 22-400, Poland
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
Gmina Końskie, Świętokrzyskie Voivodeship, 26-200, Poland
Cluj-Napoca Emergency Clinical County Hospital
Cluj-Napoca, Cluj, 400006, Romania
Dr.Carol Davila Emergency University Central Military Hospital
Bucharest, 010825, Romania
Sana Monitoring SRL
Bucharest, 011025, Romania
Colentina Clinical Hospital
Bucharest, 020125, Romania
Prof. Dr. Matei Bals Institute of Infectious Diseases
Bucharest, 021105, Romania
Fundeni Clinical Institute
Bucharest, 022328, Romania
Centrul Medical Hifu Terramed Conformal S.R.L.
Bucharest, 031864, Romania
Affidea Romania SRL
Constanța, RO-900591, Romania
Gastromedica SRL
Iași, 700506, Romania
Dr. Tirnaveanu Amelita Private Practice
Oradea, 410066, Romania
Dr. Goldis Gastroenterology Center SRL
Timișoara, 300002, Romania
Kazan State Medical University
Kazan', 420064, Russia
Moscow Clinical Scientific Center
Moscow, 111123, Russia
Moscow Regional Research Clinical Institute Na Mfvladimirskiy
Moscow, 129110, Russia
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod, 603126, Russia
Research Institute of Physiology and Basic Medicine
Novosibirsk, 630117, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
Rostov State Medical University
Rostov-on-Don, 344091, Russia
Union Clinic, LLC
Saint Petersburg, 191119, Russia
St. Elizabeth Municipal Clinical Hospital
Saint Petersburg, 195257, Russia
First St. Petersburg State Medical University n.a. I.P Pavlov
Saint Petersburg, 197022, Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, Russia
Medical University Reaviz
Samara, 443011, Russia
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
Samara, 443029, Russia
Medical Company Hepatolog, LLC
Samara, 443093, Russia
SHI Regional Clinical Hospital
Saratov, 410053, Russia
Smolensk Regional Clinical Hospital
Smoensk, 214018, Russia
Stavropol State Medical University
Stavropol, 355017, Russia
Regional Consulting and Diagnostics Centre
Tyumen, 625026, Russia
Clinical Hospital Center ''Bezanijska Kosa''
Belgrade, 11080, Serbia
University Clinical Center Nis
Niš, 18000, Serbia
General Hospital Vrsac
Vršac, 26300, Serbia
University Clinical Center Kragujevac
Kragujevac, Šumadijski Okrug, 34000, Serbia
CLINRESCO, ARWYP Medical Suites
Johannesburg, Gauteng, 1619, South Africa
Dr. J Breedt
Pretoria, Gauteng, 0002, South Africa
Dr JP Wright
Claremont, Western Cape, 7708, South Africa
Fairfield General Hospital - PPDS
Lancashire, Bury, BL9 7TD, United Kingdom
Pennine Acute Hospitals Trust
Lancashire, Bury, BL9 7TD, United Kingdom
Whipps Cross University Hospital
London, London, City of, E11 1NR, United Kingdom
North Tyneside General Hospital
North Shields, Northumberland, NE29 8NH, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, SY3 8XQ, United Kingdom
Aberdeen Royal Infirmary - PPDS
Aberdeen, AB25 2ZN, United Kingdom
Western General Hospital Edinburgh - PPDS
Edinburh, EH4 2XU, United Kingdom
Royal Gwent Hospital - PPDS
Newport, NP20 2UB, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early as per the sponsor decision to discontinue the ontamalimab clinical trial development program for inflammatory bowel diseases (IBD) for reasons unrelated to safety and efficacy.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Shire
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2017
First Posted
August 23, 2017
Study Start
February 9, 2018
Primary Completion
July 22, 2020
Study Completion
October 23, 2020
Last Updated
June 14, 2021
Results First Posted
May 7, 2021
Record last verified: 2021-06