A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease.
The primary objective of this study is to investigate the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, administered Q4W for 6 months, in comparison to placebo, in the treatment of participants suffering from chronic TED.
• Subjects voluntarily participating in the study and signing the informed consent form;
• Aged 18-75 years (inclusive), of any gender;
• Clinical diagnosis of chronic Thyroid Eye Disease (TED) , with symptoms in the study eye more than 12 months and less than 10 years.
• Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
• Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
• Diabetic subjects must have well-controlled stable disease.
• Sufficient bone marrow and organ function.
• Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.
• Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.
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