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MHB018A Treatment in Patients With Active Thyroid Eye Disease
Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd
Summary
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 active TED.
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Active Moderate-to-Severe Thyroid Eye Disease.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2025-07-22
Completion Date
2027-07-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
MHB018A
MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)
MHB018A placebo
6 subcutaneous injections of MHB018A placebo once every 4 weeks (q4w)
Locations (1)
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China