Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Last updated: April 2, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Dry Eye Disease

Treatment

Placebo

Batoclimab

Clinical Study ID

NCT05524571
IMVT-1401-3202
  • Ages > 18
  • All Genders

Study Summary

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Are ≥18 years of age at screening.

  2. Have a clinical diagnosis of TED associated with active, moderate to severe TED withthe 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 diagnosisof TED), as estimated by the Investigator/assessor

  1. Have moderate to severe active TED, as defined by European Group on Graves'Orbitopathy (EUGOGO) guidelines.

  2. Have onset of active TED within 12 months prior to screening.

  3. Have documented evidence of detectable anti-TSHR-Ab at screening.

  4. Are not expected to require immediate surgical intervention and are not planningcorrective surgery/irradiation or medical therapy for TED during the course of thestudy.

  5. Are euthyroid with the Baseline disease under control or have mild hypo- orhyperthyroidism.

Additional inclusion criteria are defined in the protocol.

Exclusion

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 betweenscreening and Baseline assessments in either eye.

  3. Have used any steroid (intravenous or oral) for the treatment of TED or otherconditions within 4 weeks prior to screening.

  4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to ≥ 1g of methylprednisolone for the treatment of TED.

  5. Have known autoimmune disease other than TED, that, in the opinion of theInvestigator, 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.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 05, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Site Number - 7565

    Sydney, 2000
    Australia

    Active - Recruiting

  • Site Number -4671

    Brugge, 8000
    Belgium

    Active - Recruiting

  • Site Number - 4672

    Bruxelles, 1070
    Belgium

    Active - Recruiting

  • Site Number - 4673

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • Site Number -4670

    Ghent, B-9000
    Belgium

    Active - Recruiting

  • Site Number - 4674

    Liège, 4000
    Belgium

    Active - Recruiting

  • Site Number - 7550

    Budapest, 1133
    Hungary

    Active - Recruiting

  • Site Number - 7552

    Pecs, 7623
    Hungary

    Active - Recruiting

  • Site Number - 7551

    Pécs, 7621
    Hungary

    Active - Recruiting

  • Site Number -9301

    Ogre, LV-5001
    Latvia

    Active - Recruiting

  • Site Number -9300

    Riga, LV-1006
    Latvia

    Active - Recruiting

  • Site Number - 9302

    Ventspils, LV-3601
    Latvia

    Active - Recruiting

  • Site Number - 7570

    Christchurch, 8013
    New Zealand

    Active - Recruiting

  • Site Number - 7572

    Hamilton, 3204
    New Zealand

    Active - Recruiting

  • Site Number -1990

    San Juan, 00921
    Puerto Rico

    Active - Recruiting

  • Site Number - 9200

    Bratislava, 82606
    Slovakia

    Active - Recruiting

  • Site Number - 9201

    Bratislava, 85107
    Slovakia

    Active - Recruiting

  • Site Number - 9203

    Bratislava, 81108
    Slovakia

    Active - Recruiting

  • Site Number - 9202

    Trenčín, 91101
    Slovakia

    Active - Recruiting

  • Site Number - 3605

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Site Number -3602

    Barcelona, 08006
    Spain

    Active - Recruiting

  • Site Number -3601

    Madrid, 28007
    Spain

    Active - Recruiting

  • Site Number -3604

    Madrid, 28034
    Spain

    Active - Recruiting

  • Site Number -3600

    Santiago De Compostela, 15706
    Spain

    Active - Recruiting

  • Site Number -3606

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Site Number -3603

    Valencia, 46026
    Spain

    Active - Recruiting

  • Site Number - 4952

    Adana, 13860
    Turkey

    Active - Recruiting

  • Site Number - 4950

    Ankara, 6100
    Turkey

    Active - Recruiting

  • Site Number - 4951

    Istanbul, 34010
    Turkey

    Active - Recruiting

  • Site Number -1520

    Pasadena, California 91107
    United States

    Completed

  • Site Number -1517

    San Francisco, California 94143
    United States

    Completed

  • Site Number -1514

    Torrance, California 90502
    United States

    Active - Recruiting

  • Site Number -1510

    Sarasota, Florida 34239
    United States

    Completed

  • Site Number -1516

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Site Number - 1526

    Livonia, Michigan 48152
    United States

    Active - Recruiting

  • Site Number - 1513

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Site Number - 1512

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Site Number - 1525

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Site Number -1515

    Bellaire, Texas 77401
    United States

    Completed

  • Site Number - 1524

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Site Number -1519

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Site Number - 1521

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Site Number -1511

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • Site Number - 1518

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.