Overview

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Immunovant Sciences GmbH
Criteria
Inclusion criteria:

1. Are ≥18 years of age at screening.

2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with a
CAS ≥4 in either eye at screening and Baseline.

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.

Additional inclusion criteria are defined in the protocol.

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 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.

Additional exclusion criteria are defined in the protocol.