Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Immunovant

Status and phase: Enrolling; Phase 3

Conditions: Thyroid Eye Disease

Treatments: Drug: Batoclimab; Other: Observational cohort study

Study type: Interventional

Funder types: Industry

Identifiers

NCT05517447

IMVT-1401-3203

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Observational cohort

Other group

Description:

Proptosis responders in feeder studies will enter in a non-treatment observational study

Treatment:

Other: Observational cohort study

Treatment Cohort

Experimental group

Description:

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

Treatment:

Drug: Batoclimab