drugset / Trial / NCT03283085

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

NCT03283085 ↗

Phase 3 Completed 557 enrolled Shire
RandomizedParallel-groupDouble-blindTreatment

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)

Timeline

Start
2018-02-27
Primary completion
2023-12-13
Completion
2023-12-13

Drugs

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