Overview
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.
Eligibility
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:
- 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.
Additional inclusion criteria are defined in the protocol.
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.
Additional exclusion criteria are defined in the protocol.