drugset / Trial / NCT05517447

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

NCT05517447 ↗

Phase 3 Terminated 109 enrolled Immunovant Sciences GmbH
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.

Timeline

Start
2022-11-06
Primary completion
2026-04-02
Completion
2026-04-02

Outcome

Outcome not reported

Stopped: “The feeder studies (i.e., IMVT-1401-3201 and 3202) for study IMVT-1401-3203 failed to achieve their pre-defined primary efficacy outcomes. Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Batoclimab Monoclonal antibody 340 mg Subcutaneous