Trials / Terminated
TerminatedNCT03259334
Efficacy and Safety Study of SHP647 as Induction 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 Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 16 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ontamalimab | 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). |
| OTHER | Placebo | Participants will receive 1 mL of sterile aqueous buffered solution. |
Timeline
- Start date
- 2018-02-09
- Primary completion
- 2020-07-22
- Completion
- 2020-10-23
- First posted
- 2017-08-23
- Last updated
- 2021-06-14
- Results posted
- 2021-05-07
Locations
207 sites across 18 countries: United States, Australia, Austria, Brazil, Croatia, Czechia, Germany, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Russia, Serbia, South Africa, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03259334. Inclusion in this directory is not an endorsement.