Actively Recruiting
MHB018A Treatment in Patients With Active Thyroid Eye Disease
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-04-02
108
Participants Needed
1
Research Sites
105 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 active TED.
CONDITIONS
Official Title
MHB018A Treatment in Patients With Active Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age between 18 and 75 years, any gender
- Clinical diagnosis of active Thyroid Eye Disease with a Clinical Activity Score of 3 or higher
- 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
- Adequate bone marrow and organ function
- Agreement to use reliable contraception if of childbearing potential; negative pregnancy test within 7 days before first dose and not breastfeeding
- Ability and willingness to comply with study treatment and evaluations for the study duration
You will not qualify if you...
- Decreased vision due to optic neuropathy within the last 6 months
- Corneal decompensation not responding to medical treatment
- Decrease in Clinical Activity Score by 2 or more points or proptosis decrease by 2 mm or more between screening and baseline
- Free thyroxine and triiodothyronine levels outside 50% above or below normal range at screening
- Previous orbital radiotherapy or eye surgery for Thyroid Eye Disease
- Corticosteroid treatment for Thyroid Eye Disease within 4 weeks before dosing or periorbital steroid injections within 3 months
- Corticosteroid use for other reasons within 4 weeks before screening (excluding topical, nasal, inhalation)
- Immunosuppressive treatments including rituximab or tocilizumab within 3 months before screening
- Previous treatment targeting IGF-1R
- Selenium and biotin use not discontinued 3 weeks before screening
- Use of investigational agents within 30 days before screening or planned during trial
- Pre-existing eye diseases that could interfere with study participation or results
- Malignant disease within past 5 years except certain skin cancers
- Recent acute cardiovascular disease or treatment within 6 months
- Poorly controlled hypertension or renal artery stenosis
- Pregnant or lactating women
- Drug or alcohol abuse during screening
- Hearing impairment or abnormal audiometry
- Inflammatory bowel disease
- Positive serum virology tests
- Live or attenuated vaccine use within 4 weeks before first dose or during study
- Major surgery within 4 weeks before first dose or planned during or shortly after study
- Known hypersensitivity to MHB018A components or similar antibodies
AI-Screening
AI-Powered Screening
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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
V
VP 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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