Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease.

Phase 1

Recruiting

• Conditions: Thyroid Eye Disease (TED); Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: CTIS2024-512648-45-00
• Lead Sponsor: Immunovant Sciences GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-31
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Are =18 years of age at screening., Have a clinical diagnosis of TED associated with active, moderate to severe TED with 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, 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.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified