Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
(FIGARO UC 302 Trial)
Recruiting in Palo Alto (17 mi)
+205 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Shire
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
SD
Study Director
Principal Investigator
Shire
Eligibility Criteria
Inclusion Criteria
- 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).
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Treatment Details
Interventions
- Ontamalimab (Monoclonal Antibodies)
- Placebo (Other)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ontamalimab 75 mgExperimental Treatment1 Intervention
Participants will receive 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.
Group II: Ontamalimab 25 mgExperimental Treatment1 Intervention
Participants will receive 25 milligram (mg) of ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo matched to ontamalimab SC injection using PFS on Week 0, Week 4, and Week 8.
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Who Is Running the Clinical Trial?
Shire
Lead Sponsor
Trials
457
Recruited
96,000+
Pierre S. Sayad
Shire
Chief Medical Officer
MD from Loma Linda University
Flemming Ornskov
Shire
Chief Executive Officer since 2013
PhD in Medicine from Aarhus University