drugset / Trial / NCT05517447
Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Batoclimab | Monoclonal antibody | 340 mg | Subcutaneous |