drugset / Trial / NCT03259334

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

NCT03259334 ↗

Phase 3 Terminated 380 enrolled Shire
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

EvaluationDrugModalityDoseRoute
Subject Ontamalimab Monoclonal antibody 25 mg Subcutaneous
Subject Ontamalimab Monoclonal antibody 75 mg Subcutaneous

Indications