Actively Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-03-30
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness, safety, and tolerability of MHB018A, a humanized antibody targeting IGF1R, in adults with chronic moderate-to-severe Thyroid Eye Disease (TED). The study compares this treatment with a placebo over a 6-month period, focusing on improving symptoms related to proptosis and other TED signs. The trial is a randomized, double-blind, placebo-controlled Phase III study sponsored by Minghui Pharmaceutical (Hangzhou) Ltd. Participants receive subcutaneous injections of either 450mg MHB018A or a placebo once every 4 weeks for 6 months. The study includes two groups: one receiving the experimental antibody and the other receiving placebo injections at the same frequency. Treatment is designed to assess the benefits and side effects of MHB018A when administered regularly in this patient population. During the 24 weeks of treatment, participants undergo evaluations including measurements of eye protrusion (proptosis), clinical activity scores (CAS), diplopia, and quality of life related to eye disease. Researchers will monitor antibody levels in the blood and check for adverse events throughout the study and at the end-of-trial visit. Participants are expected to comply with scheduled visits and treatment protocols to allow thorough assessment of outcomes and safety over the study duration.
CONDITIONS
Brief Title
MHB018A Treatment in Patients With Chronic 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
- Clinical diagnosis of chronic Thyroid Eye Disease (TED) with symptoms in the study eye present for more than 12 months and less than 10 years
- Clinical diagnosis of moderate to severe TED at screening and baseline
- Does not require immediate surgical ophthalmological intervention and no corrective surgery or orbital radiotherapy planned during the study
- Well-controlled stable diabetes if diabetic
- Sufficient bone marrow and organ function
- Eligible subjects of childbearing potential must agree to use reliable contraceptive methods; females must have a negative blood pregnancy test within 7 days before first study drug use and must not be breastfeeding
- Willing and able to comply with the treatment protocol and evaluations for the study duration
You will not qualify if you...
- Decreased best corrected visual acuity due to optic neuropathy within the last 6 months
- Corneal decompensation unresponsive to medical management
- Decrease in clinical activity score (CAS) of 2 or more points or decrease in proptosis of 2 mm or more between screening and baseline
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels outside 50% above or below normal range at screening
- Previous orbital radiotherapy or ophthalmic surgery for TED
- Corticosteroid treatment for TED within 4 weeks before first dose or periorbital/orbital steroid injections within 3 months before first dose
- Corticosteroids for reasons other than TED within 4 weeks before screening, excluding local use
- Treatment with rituximab, tocilizumab, or other immunosuppressive agents within 3 months before screening
- Previous treatment targeting IGF-1R
- Selenium and biotin use not discontinued 3 weeks prior to screening or restarted during trial
- Use of investigational agents within 30 days before screening or planned use during trial
- Pre-existing ophthalmic disease complicating study participation
- Malignant condition within past 5 years except treated basal/squamous cell carcinoma of the skin
- Acute cardiovascular disease within 6 months before first dose
- Poorly controlled hypertension or renal artery stenosis
- Pregnant or lactating women
- Drug or alcohol abuse during screening
- Hearing impairment or abnormal audiometry during screening
- Inflammatory bowel disease
- Positive serum virology tests
- Live or attenuated vaccines within 4 weeks before first dose or during study
- Major surgery within 4 weeks before first dose or planned during study or within 4 weeks after study
- Known hypersensitivity to MHB018A components or prior monoclonal antibody hypersensitivity
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 - 6 months
Participants receive subcutaneous injections of MHB018A or placebo once every 4 weeks for 6 months to treat chronic thyroid eye disease.
6 visits (in-person), one 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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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