Extension Study to Assess Batoclimab in Participants with TED.
Phase 1
Recruiting
- Conditions
- Thyroid Eye Disease (TED)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2024-512650-21-00
- Lead Sponsor
- Immunovant Sciences GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
For all participants: have completed the Week 24 visit of the feeder study., For participants assigned to the Open-label Treatment Cohort: 1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study. 2. Did not permanently discontinue study drug.
Exclusion Criteria
For all participants: in the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe batoclimab maintenance of efficacy as assessed by proptosis.;Secondary Objective: To describe the efficacy of batoclimab in participants previously treated with placebo and did not achieve proptosis response in the feeder studies., To describe the treatment effect of batoclimab in participants previously treated with batoclimab but did not achieve proptosis response in the feeder studies.;Primary end point(s): Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Proportion of proptosis responders at Week 24 in study eye in participants who were placebo non-responders in the feeder studies.;Secondary end point(s):Proportion of proptosis responders at Week 24 in study eye in participants who were batoclimab non-responders in the feeder studies.