Actively Recruiting
MHB018A Treatment in Patients With Chronic Thyroid Eye Disease
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-03-30
150
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 chronic TED.
CONDITIONS
Official Title
MHB018A Treatment in Patients With Chronic 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
- Clinical diagnosis of chronic Thyroid Eye Disease with symptoms for more than 12 months and less than 10 years
- Moderate to severe Thyroid Eye Disease at screening and baseline
- No immediate need for surgical eye intervention and no planned corrective surgery or orbital radiotherapy during the study
- Well-controlled stable diabetes if diabetic
- Sufficient bone marrow and organ function
- Use reliable contraception if of childbearing potential; negative pregnancy test within 7 days before first study drug use; not breastfeeding
- Willing and able to follow treatment and evaluation schedule for the study duration
You will not qualify if you...
- Significant vision loss due to optic neuropathy within last 6 months
- Corneal decompensation not responding to medical treatment
- Decrease in clinical activity score or proptosis between screening and baseline
- Abnormal thyroid hormone levels outside defined range at screening
- Previous orbital radiotherapy or eye surgery for Thyroid Eye Disease
- Corticosteroid use for Thyroid Eye Disease within 4 weeks before first dose or steroid injections within 3 months before first dose
- Corticosteroid use for other reasons within 4 weeks before screening (excluding local use)
- Use of rituximab, tocilizumab, or other immunosuppressants within 3 months before screening
- Previous treatment targeting IGF-1R
- Use of selenium or biotin supplements within 3 weeks before screening
- Use of investigational agents within 30 days before screening or planned during trial
- Pre-existing eye disease complicating study participation
- Cancer within past 5 years (except certain skin cancers)
- Recent acute cardiovascular disease or treatment
- Poorly controlled high blood pressure or renal artery stenosis
- Pregnant or breastfeeding women
- Drug or alcohol abuse during screening
- Hearing impairment or abnormal audiometry results
- Inflammatory bowel disease
- Positive serum viral infection tests
- Recent or planned live vaccinations
- Major surgery within 4 weeks before first dose or planned during/shortly after study
- Known hypersensitivity to MNB018A or similar antibodies
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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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