drugset / Trial / NCT03259334
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2018-02-09
- Primary completion
- 2020-07-22
- Completion
- 2020-10-23
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ontamalimab | Monoclonal antibody | 25 mg | Subcutaneous |
| Subject | Ontamalimab | Monoclonal antibody | 75 mg | Subcutaneous |