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

Beverly Hills

Site Number - 1557, Beverly Hills, California, United States, 90210

Carlsbad

Site Number - 1539, Carlsbad, California, United States, 92011

Los Angeles

Site Number - 1502, Los Angeles, California, United States, 90025

Los Angeles

Site Number - 1505, Los Angeles, California, United States, 90033

Los Angeles

Site Number - 1532, Los Angeles, California, United States, 90255

San Diego

Site Number - 1537, San Diego, California, United States, 92108

Torrance

Site Number - 1531, Torrance, California, United States, 90505

Aurora

Site Number - 1501, Aurora, Colorado, United States, 80045

Longmont

Site Number - 1544, Longmont, Colorado, United States, 80503

Newark

Site Number - 1547, Newark, Delaware, United States, 19713

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

  • * 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.
  • * 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.

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