NCT05517447

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
OTHER	Observational cohort study	Observational cohort study
DRUG	Batoclimab	Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Timeline

• Start date: 2022-11-06
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2022-08-26
• Last updated: 2026-02-18

Locations

55 sites across 14 countries: United States, Australia, Belgium, Georgia, Hungary, Israel, Italy, Latvia, New Zealand, Poland, Puerto Rico, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study