Trial intelligence / Profile preview

MHB018A in Chronic Moderate-to-Severe Thyroid Eye Disease

NCT07257185Phase 3

Key facts

Status: Active, not recruiting
Start: Mar 2026
Primary completion: Aug 2027
Countries: 1
Sponsor: Minghui Pharmaceutical, Inc.
Modality: Nanobodies (VHH), Fc-Fusion Proteins

Drugs: MHB018A
Conditions: thyroid eye disease (TED)

Overview

Phase 3, randomised, double-blind trial in thyroid eye disease (TED) comparing MHB018A Injection with MHB018A Injection Placebo (2 arms). Primary endpoint: Proptosis Responder Rate at 24 weeks. Started Mar 2026; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

MHB018A Injection
Subcutaneous injections of MHB018A 450mg once every 4 weeks (Q4W).
MHB018A Injection Placebo
Subcutaneous injections of placebo once every 4 weeks (Q4W).

Who it enrols

Adults aged 18-75 with chronic moderate-to-severe Thyroid Eye Disease (symptoms 1-10 years), excluding those with recent significant improvement, prior orbital radiotherapy/surgery, prior IGF-1R treatment, or poorly controlled hypertension/diabetes.

Endpoints

Primary

Proptosis Responder Rate24 weeks

Secondary

Overall response rate24 weeks
Change in proptosis24 weeks
Percentage of subjects with CAS of 0 or 124 weeks
Change in Clinical Activity Score24 weeks
Diplopia response rate24 weeks
Change in Quality of Life Scores24 weeks
Pharmacokinetic Parameter Trough Concentration for MHB018A24 weeks
Anti-MHB018A antibody incidenceEOT

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