A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants With Active Thyroid Eye Disease (TED)
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.
Inclusion 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:
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.
Additional inclusion criteria are defined in the protocol.
Exclusion criteria:
Additional exclusion criteria are defined in the protocol.
Hokkaido, Sapporo 060-8648, Japan