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 302
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 302)
2 other identifiers
interventional
279
21 countries
204
Brief Summary
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-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 Dec 2017
Typical duration for phase_3
204 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
December 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2020
CompletedResults Posted
Study results publicly available
April 26, 2021
CompletedApril 26, 2021
March 1, 2021
2.6 years
August 21, 2017
March 26, 2021
March 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Remission Based on Composite Score 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 derived from 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 milligram (mg) of ontamalimab 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 SC injection using PFS on Week 0, Week 4 and Week 8.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to ontamalimab SC injection using PFS on Week 0, Week 4, and Week 8.
Interventions
Participants will receive 1 mL of ontamalimab 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 less than (\<) 18 years of age must weigh \>=40 kg and must have body mass index (BMI) \>=16.5 kilogram per square metre (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. A biopsy report to confirm the histological diagnosis. b. 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 ontamalimab (formerly PF-00547659, 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.
- +48 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (207)
Arizona Digestive Health Mesa - East
Mesa, Arizona, 85206, United States
Elite Clinical Studies - Phoenix - Clinedge - PPDS
Phoenix, Arizona, 85018, United States
Advanced Research Center
Anaheim, California, 92805, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
United Medical Doctors
Encinitas, California, 92024, United States
University of California San Diego
La Jolla, California, 92037, United States
VA Long Beach Healthcare System - NAVREF - PPDS
Long Beach, California, 90822, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
United Medical Doctors
Murrieta, California, 92563, United States
Alliance Clinical Research-(Vestavia Hills)
Poway, California, 92064, United States
University of California San Francisco
San Francisco, California, 94158, United States
Care Access Research, San Pablo
San Pablo, California, 94806, United States
Renaissance Research Medical Group, INC
Cape Coral, Florida, 33991, United States
Gastro Florida
Clearwater, Florida, 33756, United States
Hi Tech and Global Research, LLc
Coral Gables, Florida, 33134, United States
ENCORE Borland-Groover Clinical Research - ERN - PPDS
Jacksonville, Florida, 32256, United States
SIH Research
Kissimmee, Florida, 34741, United States
Alliance Medical Research LLC
Lighthouse PT, Florida, 33064, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157, United States
Crystal Biomedical Research
Miami Lakes, Florida, 33065, United States
Pharma Research International Inc
Naples, Florida, 34110, United States
Bayside Clinical Research - New Port Richey
New Port Richey, Florida, 34655, United States
Accel Research Sites - St. Petersburg - ERN - PPDS
Pinellas Park, Florida, 33781, United States
BRCR Medical Center Inc.
Plantation, Florida, 33322, United States
DBC Research
Tamarac, Florida, 33321, United States
Infinite Clinical Trials
Atlanta, Georgia, 30349, United States
Atlanta Center For Gastroenterology PC
Decatur, Georgia, 30033, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024, United States
Loretto Hospital
Chicago, Illinois, 60644, United States
IL Gastroenterology Group
Gurnee, Illinois, 60031, United States
Edward Hines Jr VA Hospital - NAVREF - PPDS
Hines, Illinois, 60141, United States
Dupage Medical Group
Oakbrook Terrace, Illinois, 60181, United States
Gastroenterology Associates of Hazard
Hazard, Kentucky, 41701, United States
CroNOLA, LLC.
Houma, Louisiana, 70360, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Commonwealth Clinical Studies LLC
Brockton, Massachusetts, 02302, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047, United States
National Clinical, LLC
Hamtramck, Michigan, 48212, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
St Louis Center For Clinical Research
St Louis, Missouri, 63128, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Encompass Care
North Las Vegas, Nevada, 89086, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Southtowns Gastroenterology, PLLC
Orchard Park, New York, 14127, United States
East Carolina Gastroenterology
Jacksonville, North Carolina, 28546, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Ohio Clinical Research Partners LLC
Mentor, Ohio, 44060, United States
Veteran's Research and Education Foundation - NAVREF - PPDS
Oklahoma City, Oklahoma, 73104, United States
Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
Pittsburgh, Pennsylvania, 15240, United States
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
Garland, Texas, 75044, United States
Precision Research Institute, LLC
Houston, Texas, 77039, United States
Biopharma Informatic Inc.
Houston, Texas, 77043, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Aztec Medical Research
Houston, Texas, 77079, United States
BI Research Center
Houston, Texas, 77084, United States
Southern Star Research Institute LLC
San Antonio, Texas, 78229, United States
Mid Atlantic Health Specialists
Galax, Virginia, 24333, United States
Winchester Gastroenterology Associates
Winchester, Virginia, 22601, United States
Mayo Clinic Health System - PPDS
La Crosse, Wisconsin, 54601, United States
Sanatorio 9 de Julio SA
San Miguel de Tucumán, Tucumán Province, T4000DGI, Argentina
Fundación Favaloro
Buenos Aires, C1093AAS, Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, Argentina
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
CHU Mouscron
Mouscron, 7700, Belgium
Clinical Center Banja Luka
Banja Luka, 78000, Bosnia and Herzegovina
Second Multiprofile Hospital for Active Treatment Sofia
Sofia, Sofia-Grad, 1202, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, Sofia-Grad, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Sveta Anna
Sofia, Sofia-Grad, 1750, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, Sofia-Grad, 1784, Bulgaria
University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
Pleven, 5800, Bulgaria
Multiprofile Hospital for Active Treatment Eurohospital
Plovdiv, 4004, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
Rousse, 7002, Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, 1000, Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
Medical Center Convex EOOD
Sofia, 1680, Bulgaria
Diagnostic Consultative Centre Mladost - M OOD
Varna, 9000, Bulgaria
Percuro Clinical Research LTD
Victoria, British Columbia, V8P 2P5, Canada
Toronto Digestive Disease Associates Inc
Toronto, Ontario, M3N 2V7, Canada
Hospital Pablo Tobón Uribe
Medellín, Antioquia, 050034, Colombia
Fundación Clínica Shaio
Bogota, Cundinamarca, 111121, Colombia
Servimed S.A.S
Bucaramanga, Santander Department, 680003, Colombia
IPS Centro Médico Julián Coronel S.A.S. - PPDS
Cali, Colombia
East Viru Central Hospital
Kohta-Järve, 31025, Estonia
OÜ LV Venter
Pärnu, 80010, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Ippokrateio General Hospital of Athens
Athens, Attica, 11527, Greece
University General Hospital of Patras
Pátrai, 26504, Greece
Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloniki, 54007, Greece
Euromedica - PPDS
Thessaloniki, 54645, Greece
Bekes Megyei Kozponti Korhaz
Békéscsaba, 5600, Hungary
Magyar Honvédség Egészségügyi Központ
Budapest, 1062, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, 1136, Hungary
ENDOMEDIX Kft.
Budapest, 1139, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Bekes Megyei Kozponti Korhaz
Gyula, 5700, Hungary
Mohacsi Korhaz
Mohács, 7700, Hungary
Tolna Megyei Balassa János Kórház
Szekszárd, 7100, Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, 6600, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Jávorszky Ödön Kórház
Vác, 2600, Hungary
Csolnoky Ferenc Korhaz
Veszprém, 8200, Hungary
St Vincent's University Hospital
Dublin, Dublin 4, Ireland
Sapporo Medical University Hospital
Sapporo, Hokkaidô, 060-8543, Japan
Medical Corporation Aoyama Clinic
Kobe, Hyôgo, 650-0015, Japan
Hyogo College of Medicine
Nishinomiya-shi, Hyôgo, 663-8501, Japan
Kunimoto Hospital
Asahikawa, 070-0061, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Aizawa Hospital
Matsumoto-shi, 390-0814, Japan
Chiinkai Dojima General & Gastroenterology Clinic
Osaka, 530-0003, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
Yodogawa Christian Hospital
Osaka, 533-0024, Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, 870-0823, Japan
Bellland General Hospital
Sakai, 599-8247, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Tohoku Rosai Hospital
Sendai, 981-8563, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, 321-0293, Japan
Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
Takatsuki, 569-0086, Japan
Nihonbashi Egawa Clinic
Tokyo, 103-0028, Japan
Koukokukai Ebisu Clinic
Tokyo, 150-0013, Japan
Rafik Hariri University Hospital
Beirut, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Health Pharma Professional Research S.A de C.V.
Mexico City, Mexico City, 03810, Mexico
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, Morelos, 62170, Mexico
JM Research S.C
Cuernavaca, Morelos, 62290, Mexico
Unidad de Atencion Medica e Investigacion en Salud
Mérida, Yucatán, 97000, Mexico
Centro de Investigación Médica Aguascalientes
Aguascalientes, 20116, Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, 54769, Mexico
Centro de Investigacion Clinica Acelerada, S.C.
Distrito Federal, 07020, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Accelerium, S. de R.L. de C.V.
Monterrey, 64000, Mexico
Clinical Research Institute
Tlalnepantla, 54055, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, 45030, Mexico
Auckland City Hospital
Grafton, Auckland, 1023, New Zealand
Dunedin Hospital
Dunedin, South Island, 9016, New Zealand
Wellington Hospital
Newtown, Wellington Region, 6021, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Hospital de Braga
Braga, 4710-243, Portugal
Hospital Senhora da Oliveira - Guimaraes, E.P.E
Guimarães, 4835-044, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar do Algarve - Hospital de Portimao
Portimão, 8500-338, Portugal
Hospital de São Bernardo
Setúbal, 2910-446, Portugal
Univerzitna nemocnica Bratislava
Bratislava, 851 07, Slovakia
KM Management, spol. s r.o.
Nitra, 949 01, Slovakia
Gastro LM, s.r.o.
Prešov, 080 01, Slovakia
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gang'weondo, 26426, South Korea
CHA Bundang Medical Center, CHA University
Seongnam, Gyeonggido, 13496, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido, 16247, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 702-210, South Korea
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, 03722, South Korea
Asan Medical Center - PPDS
Seoul, 05505, South Korea
Samsung Medical Center PPDS
Seoul, 06351, South Korea
Inje University Seoul Paik Hospital
Seoul, 100-032, South Korea
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba, 14004, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Centro Medico Teknon - Grupo Quironsalud
Barcelona, 08022, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Universität Zürich
Zurich, Zürich (de), 8091, Switzerland
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33169, Turkey (Türkiye)
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
Chernivtsi, Chernivtsi Oblast, 58001, Ukraine
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine
Municipal Nonprofit Enterprise Vinnytsia City Clinical Hospital #1
Vinnytsia, Vinnytsia Oblast, 21001, Ukraine
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro, 49005, Ukraine
LLC Medical Center Family Medicine Clinic
Dnipro, 49038, Ukraine
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipro, 49074, Ukraine
Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
Kharkiv, 61039, Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, 61058, Ukraine
MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
Kharkiv, 61166, Ukraine
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
Kherson, 73000, Ukraine
Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
Kryvyi Rih, 50056, Ukraine
Medical Center of LLC Medical Clinic Blagomed
Kyiv, 01023, Ukraine
Kyiv City Clinical Hospital #18
Kyiv, 01030, Ukraine
Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
Kyiv, 01033, Ukraine
Municipal Institution of KRC Kyiv Regional Hospital #2
Kyiv, 04073, Ukraine
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, 04107, Ukraine
Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
Lviv, 79007, Ukraine
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
Lviv, 79059, Ukraine
Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
Odesa, 65025, Ukraine
MNPE Central City Clinical Hospital of Uzhhorod City Council
Uzhhorod, 88000, Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia, 21009, Ukraine
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
Vinnytsia, 21018, Ukraine
City Clinical Hospital #1
Vinnytsia, 21029, Ukraine
Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"
Vinnytsia, 21029, Ukraine
Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
Zaporizhzhia, 69000, Ukraine
MNPE City Hospital No. 6 of Zaporizhzhia City Council
Zaporizhzhia, 69035, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated as per the sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
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
December 5, 2017
Primary Completion
July 15, 2020
Study Completion
October 6, 2020
Last Updated
April 26, 2021
Results First Posted
April 26, 2021
Record last verified: 2021-03