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Evaluating 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)

PHASE3 · Immunovant Sciences GmbH · NCT05517421

This study is testing if a new medication called batoclimab can help people with moderate to severe active Thyroid Eye Disease feel better after 24 weeks compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorImmunovant Sciences GmbH (industry)
Drugs / interventionsbatoclimab
Locations93 sites (Beverly Hills, California and 92 other locations)
Trial IDNCT05517421 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the efficacy of batoclimab, a monoclonal antibody, administered subcutaneously for 12 weeks, followed by a lower dose for an additional 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). Eligible participants must meet specific criteria related to their condition, including proptosis measurements and the presence of certain antibodies. The study aims to provide insights into the potential benefits of batoclimab for managing TED symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe active Thyroid Eye Disease and specific clinical characteristics.

Not a fit: Patients who require immediate surgical intervention or are planning other treatments for Thyroid Eye Disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients with active Thyroid Eye Disease.

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

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* Are ≥18 years of age at screening.
* 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:

    1. Proptosis ≥ 18 mm and/or
    2. Proptosis ≥ 3 mm increase from participant's baseline (prior to diagnosis of TED), as estimated by the Investigator/assessor
* Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.
* Have onset of active TED within 12 months prior to screening.
* Have documented evidence of detectable anti-TSHR-Ab at screening.
* 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.
* Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism.

Additional inclusion criteria are defined in the protocol.

Exclusion criteria:

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

Additional exclusion criteria are defined in the protocol.

Where this trial is running

Beverly Hills, California and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

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 →

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

Last reviewed 2026-05-15 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.