drugset
drugset / Trial / NCT04790916

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)

NCT04790916 ↗

Phase 2 Terminated 2 enrolled Hoffmann-La Roche
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.

Timeline

Start
2021-04-19
Primary completion
2021-11-18
Completion
2021-11-18

Outcome

Outcome not reported

Stopped: “A lack of efficacy was seen with RO7049665 in a study of ulcerative colitis. This reduces the likelihood that the drug is effective in autoimmune hepatitis.”

Drugs

EvaluationDrugModalityDoseRoute
Subject MELREDABLEUKIN ALFA Protein / enzyme biologic 3.5 mg Subcutaneous
Subject MELREDABLEUKIN ALFA Protein / enzyme biologic 7.5 mg Subcutaneous

Indications

autoimmune hepatitis