Trials / Completed
CompletedNCT03283085
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 557 (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 safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 25 mg Ontamalimab | Ontamalimab SC solution for injection |
| DRUG | 75 mg Ontamalimab | Ontamalimab SC solution for injection |
Timeline
- Start date
- 2018-02-27
- Primary completion
- 2023-12-13
- Completion
- 2023-12-13
- First posted
- 2017-09-14
- Last updated
- 2024-06-21
- Results posted
- 2024-06-21
Locations
419 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 NCT03283085. Inclusion in this directory is not an endorsement.