Trials / Completed
CompletedNCT03290781
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 366 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 16 Years – 81 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ontamalimab | Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg). |
| OTHER | Placebo | Participants will receive 1 mL of sterile aqueous buffered solution. |
Timeline
- Start date
- 2018-04-04
- Primary completion
- 2021-07-01
- Completion
- 2021-07-01
- First posted
- 2017-09-25
- Last updated
- 2022-01-14
- Results posted
- 2022-01-14
Locations
401 sites across 37 countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Colombia, Croatia, Czechia, Estonia, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03290781. Inclusion in this directory is not an endorsement.