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

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05517447

Enrollment

109

Registered

2022-08-26

Start date

2022-11-06

Completion date

2026-04-02

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease

Keywords

Batoclimab, Thyroid eye disease, IMVT-1401, Monoclonal antibody, Autoimmune disorders, Graves' Ophthalmopathy, Graves' Orbitopathy

Brief 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.

Interventions

OTHERObservational cohort study

Observational cohort study

DRUGBatoclimab

Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies	Up to Week 24

Secondary

Measure	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

Countries

Australia, Belgium, Georgia, Hungary, Israel, Italy, Latvia, New Zealand, Poland, Puerto Rico, Slovakia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026