Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Description

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.

Conditions

Thyroid Eye Disease

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Study Overview

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Study Details

Study overview

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.

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

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Condition
Thyroid Eye Disease
Intervention / Treatment

-

Contacts and Locations

Pasadena

Site Number -1520, Pasadena, California, United States, 91107

San Francisco

Site Number -1517, San Francisco, California, United States, 94143

Torrance

Site Number -1514, Torrance, California, United States, 90502

Sarasota

Site Number -1510, Sarasota, Florida, United States, 34239

Louisville

Site Number -1516, Louisville, Kentucky, United States, 40202

Livonia

Site Number - 1526, Livonia, Michigan, United States, 48152

Rochester

Site Number - 1513, Rochester, Minnesota, United States, 55905

Winston-Salem

Site Number - 1512, Winston-Salem, North Carolina, United States, 27157

Portland

Site Number - 1525, Portland, Oregon, United States, 97239

Bellaire

Site Number -1515, Bellaire, Texas, United States, 77401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovant Sciences GmbH,

Study Record Dates

2025-01