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RECRUITING
NCT06989918
PHASE3

MHB018A Treatment in Patients With Active Thyroid Eye Disease

Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

MHB018A

MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)

DRUG

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