NCT07262476

Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease

A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.

Detailed description

The primary objective of this study is to evaluate the improvement in proptosis from baseline (defined as the most recent measurement prior to the first dose in this study) following treatment with MHB018A Injection in subjects with active or chronic TED who previously received placebo in either the MHB018A-P-301 or MHB018A-P-302 studies, and the safety and tolerability of MHB018A Injection in TED subjects.

Conditions

• Thyroid Eye Disease (TED)

Interventions

Type	Name	Description
DRUG	MHB018A injection	MHB018A 450mg for subcutaneous injection once every 4 weeks (Q4W)

Timeline

• Start date: 2026-01-09
• Primary completion: 2029-01-31
• Completion: 2030-01-31
• First posted: 2025-12-03
• Last updated: 2026-03-30

Locations

1 site across 1 country: China