Actively Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection in Subjects With Active Moderate-to-Severe Thyroid Eye Disease
Led by Minghui Pharmaceutical (Hangzhou) Ltd · Updated on 2026-04-02
108
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and tolerability of MHB018A, a humanized anti-IGF1R antibody, in adults with active moderate-to-severe Thyroid Eye Disease (TED). This Phase III, randomized, double-blind, placebo-controlled trial compares MHB018A to placebo to see if it can reduce eye bulging (proptosis) without worsening the other eye. The study aims to better understand treatment options for people suffering from this condition. Participants will receive either 6 subcutaneous injections of MHB018A at a dose of 450 mg once every 4 weeks, or 6 injections of a matching placebo on the same schedule, over a 6-month treatment period. The trial includes two groups: one receiving the active drug and one receiving placebo, both administered under medical supervision. The study monitors responses at 24 weeks, focusing on eye improvement and other health measures. During the study, participants will have regular evaluations including eye exams to measure changes in proptosis and clinical activity scores. Researchers will also assess quality of life, eye movement problems, and antibody responses to the drug. Safety and tolerability will be closely monitored, and participants are expected to follow the treatment protocol and attend all scheduled visits over the 6-month period. The main outcome is the percentage of participants with a meaningful reduction in eye bulging without worsening the other eye.
CONDITIONS
Brief Title
MHB018A Treatment in Patients With Active 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 to 75 years, any gender
- Clinical diagnosis of active Thyroid Eye Disease with a Clinical Activity Score (CAS) of 3 or higher at screening and baseline
- Moderate to severe Thyroid Eye Disease at screening and baseline
- Does not require immediate surgical ophthalmological intervention; no corrective surgery or orbital radiotherapy planned during the study
- Diabetic subjects must have well-controlled stable disease
- Sufficient bone marrow and organ function
- Subjects of childbearing potential must agree to use reliable contraception; females must have a negative pregnancy test within 7 days before first dose 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 with recent vision loss
- Corneal decompensation unresponsive to medical treatment
- Decrease in Clinical Activity Score of 2 points or more, or proptosis decrease of 2 mm or more between screening and baseline
- Free thyroxine (FT4) and free triiodothyronine (FT3) levels outside 50% above or below normal at screening
- Previous orbital radiotherapy or ophthalmic surgery for Thyroid Eye Disease
- Use of oral or intravenous corticosteroids or corticosteroid eye drops/ointments for Thyroid Eye Disease within 4 weeks before first dose; periorbital/orbital steroid injections within 3 months before first dose
- Use of corticosteroids for reasons other than Thyroid Eye Disease within 4 weeks before screening, excluding local use
- Previous treatment with rituximab, tocilizumab, or other immunosuppressive agents within 3 months before screening
- Previous treatment targeting IGF-1R
- Selenium and biotin supplements not discontinued 3 weeks prior to screening or restarted during trial
- Use of investigational agents within 30 days prior to screening or planned during trial
- Pre-existing ophthalmic disease that could interfere with study participation
- Malignant condition within past 5 years, except treated basal/squamous cell skin carcinoma
- 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
- Biopsy-proven or suspected inflammatory bowel disease
- Positive serum virology tests
- Use or planned use of live or attenuated vaccines within 4 weeks before first dose or during study
- Major surgery within 4 weeks before first dose or planned during or within 4 weeks after study
- Known hypersensitivity to study drug components or monoclonal antibodies
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 - Approximately 24 weeks
Participants receive 6 subcutaneous injections of MHB018A or placebo once every 4 weeks.
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
V
VP 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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