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New drug shows promise for bulging eyes in thyroid disease

NCT ID NCT05517421

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested a drug called batoclimab in 114 adults with active, moderate-to-severe thyroid eye disease (TED). Participants received weekly injections of batoclimab or a placebo for 24 weeks. The main goal was to see if the drug could reduce eye bulging (proptosis) by at least 2 millimeters without worsening in the other eye. The study is complete, and results will show whether batoclimab is a safe and effective treatment for this condition.

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 completed Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects from immune suppression are possible.

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

114 people

The number who actually took part.

Started

Nov 2022

Finished

Nov 2025

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: * 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.

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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 - 1500

    Roanoke, Virginia, 24018, United States

  • Site Number - 1501

    Aurora, Colorado, 80045, United States

  • Site Number - 1502

    Los Angeles, California, 90025, United States

  • Site Number - 1504

    Miami, Florida, 33136, United States

  • Site Number - 1505

    Los Angeles, California, 90033, United States

  • Site Number - 1506

    Boston, Massachusetts, 02130, United States

  • Site Number - 1507

    Portland, Oregon, 97232, United States

  • Site Number - 1508

    Houston, Texas, 77030, United States

  • Site Number - 1509

    Madison, Wisconsin, 53705, United States

  • Site Number - 1530

    Chapel Hill, North Carolina, 27517, United States

  • Site Number - 1531

    Torrance, California, 90505, United States

  • Site Number - 1532

    Los Angeles, California, 90255, United States

  • Site Number - 1534

    Chicago, Illinois, 60610, United States

  • Site Number - 1535

    Baltimore, Maryland, 21231, United States

  • Site Number - 1536

    West Palm Beach, Florida, 33401, United States

  • Site Number - 1537

    San Diego, California, 92108, United States

  • Site Number - 1538

    Port Charlotte, Florida, 33952, United States

  • Site Number - 1539

    Carlsbad, California, 92011, United States

  • Site Number - 1540

    Las Vegas, Nevada, 89184, United States

  • Site Number - 1542

    Tampa, Florida, 33603, United States

  • Site Number - 1544

    Longmont, Colorado, 80503, United States

  • Site Number - 1545

    Iowa City, Iowa, 52242, United States

  • Site Number - 1547

    Newark, Delaware, 19713, United States

  • Site Number - 1550

    Columbus, Ohio, 43215, United States

  • Site Number - 1551

    Dallas, Texas, 75231, United States

  • Site Number - 1554

    Stockbridge, Georgia, 30281, United States

  • Site Number - 1556

    Warwick, Rhode Island, 02886, United States

  • Site Number - 1557

    Beverly Hills, California, 90210, United States

  • Site Number - 1558

    Mesquite, Texas, 75149, United States

  • Site Number - 2500

    Ottawa, Ontario, K1H 8L6, Canada

  • Site Number - 2501

    Montreal, Quebec, H1T 2M4, Canada

  • Site Number - 2502

    Edmonton, Alberta, T6G 2E1, Canada

  • Site Number - 3100

    Warsaw, 02-097, Poland

  • Site Number - 3101

    Krakow, 30-688, Poland

  • Site Number - 3102

    Lublin, 20-562, Poland

  • Site Number - 3103

    Katowice, 40-514, Poland

  • Site Number - 3104

    Lublin, 20-171, Poland

  • Site Number - 3105

    Lublin, 60-354, Poland

  • Site Number - 3106

    Olsztyn, 10-561, Poland

  • Site Number - 3107

    Gliwice, 44-102, Poland

  • Site Number - 3450

    Tbilisi, 0159, Georgia

  • Site Number - 3451

    Tbilisi, 0159, Georgia

  • Site Number - 3452

    Tbilisi, 0101, Georgia

  • Site Number - 3453

    Tbilisi, 0186, Georgia

  • Site Number - 3454

    Tbilisi, 0114, Georgia

  • Site Number - 3455

    Tbilisi, 0114, Georgia

  • Site Number - 4760

    Ramat Gan, 5265601, Israel

  • Site Number - 4761

    Jerusalem, 91120, Israel

  • Site Number - 4762

    Petah Tikva, 4941492, Israel

  • Site Number - 4763

    Nahariya, 2210000, Israel

  • Site Number - 4764

    Afula, 1834111, Israel

  • Site Number - 6200

    Pisa, 56100, Italy

  • Site Number - 6201

    Pisa, 56124, Italy

  • Site Number - 6202

    Roma, 00189, Italy

  • Site Number - 6203

    Milan, 20149, Italy

  • Site Number - 6204

    Milan, 20122, Italy

  • Site Number - 6205

    Naples, 80131, Italy

  • Site Number - 6206

    Bologna, 40138, Italy

  • Site Number - 6207

    Catania, CAP95125, Italy

  • Site Number - 6208

    Rome, 00161, Italy

  • Site Number - 6209

    Palermo, 90127, Italy

  • Site Number - 6604

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Site Number - 6608

    Frankfurt am Main, Hesse, 60318, Germany

  • Site Number - 6609

    Tübingen, Baden - Wuttemberg, 72076, Germany

  • Site Number - 6610

    Leipzig, Saxony, 04103, Germany

  • Site Number - 6611

    Schwerin, 19049, Germany

  • Site Number - 7300

    Manchester, M139WL, United Kingdom

  • Site Number - 7302

    Newcastle upon Tyne, NE1 3BZ, United Kingdom

  • Site Number - 7303

    London, EC1V 2PD, United Kingdom

  • Site Number - 7305

    Guildford, GU2 7XX, United Kingdom

  • Site Number - 7308

    Sheffield, S102SB, United Kingdom

  • Site Number - 7309

    Leicester, LE15WW, United Kingdom

  • Site Number - 7310

    Hull, HU6 7RX, United Kingdom

  • Site Number - 7311

    London, SE17EH, United Kingdom

  • Site Number - 7312

    London, W1T 6AH, United Kingdom

  • Site Number - 7313

    London, W1T 7HA, United Kingdom

  • Site Number - 7401

    Fukuoka, 812-0011, Japan

  • Site Number - 7402

    Kitakyushu, 807-8556, Japan

  • Site Number - 7403

    Hyōgo, 663-8501, Japan

  • Site Number - 7404

    Tottori, 683-8504, Japan

  • Site Number - 7406

    Nagoya, 467-8602, Japan

  • Site Number - 7407

    Nagasaki, 852-8501, Japan

  • Site Number - 7408

    Osaka, 545-0051, Japan

  • Site Number - 7409

    Tokyo, 173-8610, Japan

  • Site Number - 7410

    Kanagawa, 230-8765, Japan

  • Site Number - 7411

    Ibaraki, 305-8576, Japan

  • Site Number - 7412

    Nankoku, 783-0043, Japan

  • Site Number - 7413

    Yamaguchi, 754-0002, Japan

  • Site Number - 7414

    Miyazaki, 889-1692, Japan

  • Site Number - 7415

    Maebashi, Gunma, 371-8511, Japan

  • Site Number - 7416

    Kumamoto, 860-8556, Japan

  • Site Number - 7417

    Kobe, 657-0068, Japan

  • Site Number- 7418

    Hokkaido, Sapporo, 060-8648, Japan

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Other studies related to the condition(s) this trial covers.