Actively Recruiting
Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-03-30
258
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
CONDITIONS
Official Title
Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Aged 18 to 75 years, any gender
- Completed 24-week double-blind treatment in MHB018A-P-301 or MHB018A-P-302 study and enrolled within 28 days after Week 24 visit (except relapse cases during safety follow-up)
- Proptosis non-responder at Week 24 or meet retreatment criteria during safety follow-up
- Do not require immediate surgical eye intervention and no surgery or orbital radiotherapy planned during study
- Diabetic subjects must have well-controlled stable disease
- Have sufficient bone marrow and organ function
- If of childbearing potential, agree to use reliable contraception; females must have negative pregnancy test within 7 days before first drug use and must not be breastfeeding
- Willing and able to comply with treatment and evaluations for 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 and free triiodothyronine levels less than 50% above or below normal range at screening
- Received any TED treatment, intravenous corticosteroids, immunosuppressants, or investigational drugs since last MHB018A trial visit
- Pre-existing eye diseases that prevent participation or complicate results
- Acute cardiovascular disease history or treatment within 6 months before first dose
- Poorly controlled hypertension (systolic 65 160 mmHg or diastolic 65 100 mmHg) or renal artery stenosis
- Pregnant or lactating women
- Tinnitus or other hearing impairment
- Poor compliance, severe systemic disease, or other reasons making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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