Actively Recruiting
A Phase III, Multicenter, Open-Label Extension Study to Evaluate the Efficacy and Safety of MHB018A Injection in Subjects With Thyroid Eye Disease
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-03-30
258
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MHB018A Injection in people with moderate-to-severe Thyroid Eye Disease (TED) in this multicenter, open-label extension study. The study aims to assess whether the treatment improves proptosis (eye bulging) compared to earlier baseline measurements and to monitor the safety and tolerability of MHB018A in participants who previously received placebo in related studies. This Phase III trial focuses on those with active or chronic TED and builds on prior research findings. Participants receive subcutaneous injections of MHB018A at a dose of 450 mg once every four weeks. This dosing continues throughout the open-label extension period, allowing researchers to observe longer-term effects and safety. The study includes subjects who completed an earlier 24-week double-blind treatment phase and met specific criteria related to response or relapse, with no planned corrective eye surgery or radiotherapy during the study. During the study, participants undergo regular assessments including measurements of proptosis, clinical activity scores, diplopia response, and quality of life related to eye disease. Safety monitoring tracks adverse events up to 24 weeks and at the end of the trial. Researchers also evaluate pharmacokinetics and relapse rates. Participants are expected to follow the treatment schedule and attend all evaluation visits over the study duration, which supports comprehensive data collection on the effects and safety of MHB018A.
CONDITIONS
Brief Title
Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily participating in the study and signing the informed consent form
- Aged 18-75 years (inclusive), of any gender
- Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, within 28 days after Week 24 visit of the previous study or meet relapse criteria during safety follow-up
- Proptosis non-responder at Week 24 or meet retreatment criteria for relapse during safety follow-up
- Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy planned during the study
- Diabetic subjects must have well-controlled stable disease
- Sufficient bone marrow and organ function
- Eligible subjects of childbearing potential must agree to use reliable contraception; females must have negative pregnancy test within 7 days before first dose and not be breastfeeding
- Willing and able to comply with study treatment protocol and evaluations for the study duration
You will not qualify if you...
- Decreased best corrected visual acuity due to optic neuropathy within last 6 months
- Corneal decompensation unresponsive to medical management
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below normal range at screening
- Received treatment for TED, intravenous corticosteroids, immunosuppressive agents, or investigational drug from last visit of prior trial until this study
- Pre-existing ophthalmic disease complicating study participation or result interpretation
- Acute cardiovascular disease history or treatment within 6 months before first dose
- Poorly controlled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg) or renal artery stenosis
- Pregnant or lactating women
- Tinnitus or other hearing impairment
- Poor compliance, severe systemic disease, or other reasons making subject unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive subcutaneous injections of MHB018A 450mg once every 4 weeks to treat thyroid eye disease.
6 visits (in-person) for injections every 4 weeks
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 201419
Actively Recruiting
Research Team
C
CMO/ Senior Vice President of R&D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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