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Assessing Batoclimab for Active Thyroid Eye Disease

A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)

Phase 3 Interventional Immunovant Sciences GmbH · NCT05524571

This study is testing if a new medication called batoclimab can help people with moderate to severe active Thyroid Eye Disease feel better by reducing their eye bulging over 24 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorImmunovant Sciences GmbH Industry-sponsored
Drugs / interventionsbatoclimab
Locations44 sites (Pasadena, California and 43 other locations)
Trial IDNCT05524571 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of batoclimab, a monoclonal antibody, administered subcutaneously for 12 weeks, followed by a lower dose for another 12 weeks, compared to a placebo. The primary focus is on the proptosis responder rate at Week 24 in participants diagnosed with moderate to severe active Thyroid Eye Disease (TED). Participants must meet specific criteria, including a clinical diagnosis of TED and evidence of worsened proptosis. The study aims to determine if batoclimab can effectively reduce symptoms associated with this autoimmune disorder.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with active, moderate to severe Thyroid Eye Disease and specific clinical indicators of worsened proptosis.

Not a fit: Patients who require immediate surgical intervention or are planning corrective surgery or other medical therapies for TED during the study may not benefit.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Thyroid Eye Disease by reducing proptosis.

How similar studies have performed: Other studies involving monoclonal antibodies for autoimmune conditions have shown promise, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. Are ≥18 years of age at screening.
2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with the following at screening and Visit 0:

   * A CAS ≥ 4 in either eye, and
   * Clinical evidence of worsened proptosis with:

     * Proptosis ≥ 18 mm and/or
     * Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
4. Have onset of active TED within 12 months prior to screening.
5. Have documented evidence of detectable anti-TSHR-Ab at screening.
6. Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
7. Are euthyroid with the Baseline disease under control or have mild hypo- or hyperthyroidism.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

1. Have decreased best corrected visual acuity due to optic neuropathy.
2. Have at least a 2-point decrease in CAS or ≥2 mm decrease in proptosis between screening and Baseline assessments in either eye.
3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.
4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1 g of methylprednisolone for the treatment of TED.
5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.
6. Had previous orbital irradiation or surgery for TED.

Additional exclusion criteria are defined in the protocol.

Where this trial is running

Pasadena, California and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Thyroid Eye DiseaseBatoclimabThyroid eye diseaseIMVT-1401Monoclonal antibodyAutoimmune disordersGraves' OphthalmopathyGraves' Orbitopathy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.