Clinical trial
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
ClinicalTrials.gov ID: NCT03283085
Sponsor: Shire
Information provided by: Shire (Responsible Party)
Last Update Posted: 2023-05-23
Brief 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)
OFFICIAL TITLE
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
INTERVENTION / TREATMENT
Drug: 25 mg Ontamalimab
Drug: 75 mg Ontamalimab
| Category | Value |
|---|---|
| Study Start (Actual) | 2018-02-27 |
| Primary Completion (Estimated) | 2023-12-31 |
| Study Completion (Estimated) | 2023-12-31 |
| Enrollment (Actual) | 557 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
SHP647-304
2017-000574-11 (EudraCT Number)
|