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New drug batoclimab aims to reduce eye bulging in thyroid eye disease

NCT ID NCT05524571

Disease control Sponsor: Immunovant Sciences GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether batoclimab, an injected antibody, can reduce eye bulging (proptosis) in people with active, moderate-to-severe thyroid eye disease. 86 participants received weekly injections of batoclimab or a placebo for 24 weeks. The main goal was to see how many people had at least a 2-millimeter reduction in eye protrusion without worsening in the other eye.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
batoclimab (a monoclonal antibody injection)
What this could lead to
If successful, batoclimab could offer a new treatment option to reduce eye bulging and inflammation in people with active thyroid eye disease.
What could go wrong
This is a relatively small Phase 3 trial (86 participants), and results may not apply to all patients. The drug may cause side effects or fail to show meaningful benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

86 people

The number who actually took part.

Started

Jan 2023

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroid eye disease

Contacts and locations

Locations

  • Site Number - 1512

    Winston-Salem, North Carolina, 27157, United States

  • Site Number - 1513

    Rochester, Minnesota, 55905, United States

  • Site Number - 1518

    Milwaukee, Wisconsin, 53226, United States

  • Site Number - 1521

    Seattle, Washington, 98104, United States

  • Site Number - 1524

    McAllen, Texas, 78503, United States

  • Site Number - 1525

    Portland, Oregon, 97239, United States

  • Site Number - 1526

    Livonia, Michigan, 48152, United States

  • Site Number - 3605

    Barcelona, 08035, Spain

  • Site Number - 4672

    Brussels, 1070, Belgium

  • Site Number - 4673

    Brussels, 1200, Belgium

  • Site Number - 4674

    Liège, 4000, Belgium

  • Site Number - 4950

    Ankara, 6100, Turkey (Türkiye)

  • Site Number - 4951

    Istanbul, 34010, Turkey (Türkiye)

  • Site Number - 4952

    Adana, 13860, Turkey (Türkiye)

  • Site Number - 6603

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Site Number - 7550

    Budapest, 1133, Hungary

  • Site Number - 7551

    Pécs, 7621, Hungary

  • Site Number - 7552

    Pécs, 7623, Hungary

  • Site Number - 7565

    Sydney, 2000, Australia

  • Site Number - 7570

    Christchurch, 8013, New Zealand

  • Site Number - 7572

    Hamilton, 3204, New Zealand

  • Site Number - 9200

    Bratislava, 82606, Slovakia

  • Site Number - 9201

    Bratislava, 85107, Slovakia

  • Site Number - 9202

    Trenčín, 91101, Slovakia

  • Site Number - 9203

    Bratislava, 81108, Slovakia

  • Site Number - 9302

    Ventspils, LV-3601, Latvia

  • Site Number -1510

    Sarasota, Florida, 34239, United States

  • Site Number -1511

    Morgantown, West Virginia, 26506, United States

  • Site Number -1514

    Torrance, California, 90502, United States

  • Site Number -1515

    Bellaire, Texas, 77401, United States

  • Site Number -1516

    Louisville, Kentucky, 40202, United States

  • Site Number -1517

    San Francisco, California, 94143, United States

  • Site Number -1519

    San Antonio, Texas, 78215, United States

  • Site Number -1520

    Pasadena, California, 91107, United States

  • Site Number -1990

    San Juan, 00921, Puerto Rico

  • Site Number -3600

    Santiago de Compostela, 15706, Spain

  • Site Number -3601

    Madrid, 28007, Spain

  • Site Number -3602

    Barcelona, 08006, Spain

  • Site Number -3603

    Valencia, 46026, Spain

  • Site Number -3604

    Madrid, 28034, Spain

  • Site Number -3606

    Seville, 41009, Spain

  • Site Number -4670

    Ghent, B-9000, Belgium

  • Site Number -4671

    Bruges, 8000, Belgium

  • Site Number -9300

    Riga, LV-1006, Latvia

  • Site Number -9301

    Ogre, LV-5001, Latvia

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