Minghui Pharmaceutical (Hangzhou) Ltd
The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with active moderate-to-severe TED.
The investigational drug, MHB018A, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with active moderate-to-severe TED.
Inclusion Criteria: 1. Body weight ≤ 120 kg. 2. Clinical diagnosis of active TED with documented medical evidence of symptoms and signs in the study eye occurring within the 12 months prior to study screening. The CAS of the study eye at screening and baseline must be ≥ 3 points (7-point scale). 3. Clinical diagnosis of moderate-to-severe TED at screening and baseline. 4. Do not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study. 5. Diabetic participants must have well-controlled stable disease. Exclusion Crite…
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
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