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Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

NCT05517447 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2026-04-29

No results posted yet for this study

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

OTHER

Observational cohort study

Observational cohort study

DRUG

Batoclimab

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

Sponsors & Collaborators

  • Immunovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-06
Primary Completion
2026-04-02
Completion
2026-04-02
FDA Drug
Yes

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05517447 on ClinicalTrials.gov