Trials / Terminated
TerminatedNCT03259308
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 302)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 279 (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 patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Detailed description
27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ontamalimab | 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). |
| DRUG | Placebo | Participants will receive 1 mL of sterile aqueous buffered solution. |
Timeline
- Start date
- 2017-12-05
- Primary completion
- 2020-07-15
- Completion
- 2020-10-06
- First posted
- 2017-08-23
- Last updated
- 2021-04-26
- Results posted
- 2021-04-26
Locations
207 sites across 22 countries: United States, Argentina, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Colombia, Estonia, Greece, Hungary, Ireland, Japan, Lebanon, Mexico, New Zealand, Portugal, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03259308. Inclusion in this directory is not an endorsement.