Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label Extension Study for Participants Who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)

Conditions
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Thyroid Eye Disease

Intervention / Treatment
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* Other: Observational cohort study
* Drug: Batoclimab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: For all participants: 1. Have completed the Week 24 visit of the feeder study. For participants assigned to the Open-label Treatment Cohort: Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study. Did not permanently discontinue batoclimab Additional inclusion criteria are defined in the protocol. Exclusion criteria: For all participants: 1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Observational cohort<br>Proptosis responders in feeder studies will enter in a non-treatment observational study | Other: Observational cohort study<br>* Observational cohort study<br>|
| Experimental: Treatment Cohort<br>Proptosis non-responders in feeder studies will be administered batoclimab of 680 milligram (mg) subcutaneous (SC) for 12 weeks followed by 340 mg SC for 12 weeks | Drug: Batoclimab<br>* Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody<br>* Other names: IMVT-1401;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies |  | Up to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies |  | At Week 24 | 
| Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies |  | At Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Batoclimab, Thyroid eye disease, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Graves' Ophthalmopathy, Graves' Orbitopathy