Extension Study to Assess Batoclimab in Participants with TED

Phase 1

• Conditions: Thyroid Eye Disease (TED); MedDRA version: 23.1Level: LLTClassification code 10084358Term: Thyroid eye diseaseSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2022-002839-66-HU
• Lead Sponsor: Immunovant Sciences, GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-21
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

For all participants:
1. Have completed the Week 24 visit of the feeder study.

For participants assigned to the Open-label Treatment Cohort:
1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.
2. Did not permanently discontinue batoclimab

Additional inclusion criteria are defined in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

For all participants:
1. In the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.

Study & Design

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