A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
- Sponsor: Immunovant Sciences GmbH
- Principal Investigator: Suzanne Van Landingham, MD
- Study Coordinator: Kris Dietzman
Study Objective:
To evaluate the efficacy of batoclimab compared to placebo as assessed by proptosis and Clinical Activity Score (CAS).
Study Design:
Participants will be randomized 2:1 to receive batoclimab 680 mg SQ for 12 weeks followed by 340 mg SQ for 12 weeks or placebo SQ for 24 weeks. The total study duration is 32 weeks.
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 at screening and Baseline.
- 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.
Contact Kris Dietzman with questions, (608) 263-9035
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