Phase 3 Study of MHB018A Injection to Treat Active Moderate-to-Severe Thyroid Eye Disease in Adults

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, in adults with active moderate-to-severe Thyroid Eye Disease TED. This Phase III, randomized, double-blind, placebo-controlled trial compares MHB018A to placebo to see if it can reduce eye bulging proptosis without worsening the other eye. The study aims to better understand treatment options for people suffering from this condition. Participants will receive either 6 subcutaneous injections of MHB018A at a dose of 450 mg once every 4 weeks, or 6 injections of a matching placebo on the same schedule, over a 6-month treatment period. The trial includes two groups one receiving the active drug and one receiving placebo, both administered under medical supervision. The study monitors responses at 24 weeks, focusing on eye improvement and other health measures. During the study, participants will have regular evaluations including eye exams to measure changes in proptosis and clinical activity scores. Researchers will also assess quality of life, eye movement problems, and antibody responses to the drug. Safety and tolerability will be closely monitored, and participants are expected to follow the treatment protocol and attend all scheduled visits over the 6-month period. The main outcome is the percentage of participants with a meaningful reduction in eye bulging without worsening the other eye.

MHB018A Treatment in Patients With Active Thyroid Eye Disease