NCT07622121Not yet recruitingPhase 3
A Phase III, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of MHB018A Injection Treatment in Subjects With Chronic Moderate-to-Severe Thyroid Eye Disease
Minghui Pharmaceutical (Hangzhou) Ltd0 sites135 target enrollmentStarted: December 1, 2026Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 135
Study Overview
Brief Summary
The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.
Detailed Description
The primary objective of this study is to evaluate the efficacy of MHB018A injection compared with placebo in participants with chronic moderate-to-severe TED.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 more than 12 months and less than 10 years.
- •Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline.
- •Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study.
- •Diabetic subjects must have well-controlled stable disease.
- •Sufficient bone marrow and organ function.
- •Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods; female subjects of childbearing potential must have a negative blood pregnancy test within 7 days before the first use of the study drug and must not be breastfeeding.
- •Subject is willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the study.
Exclusion Criteria
- •Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision within the last 6 months of two lines of Snellen chart, new visual field defect or color defect secondary to optic nerve involvement.
- •Corneal decompensation unresponsive to medical management.
- •Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.
- •Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
- •Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.
- •Subjects who received oral or intravenous corticosteroids or corticosteroid eye drops/ointments for TED within 4 weeks before the first dose; subjects who received periorbital/orbital steroid injections within 3 months before the first dose.
- •Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).
- •Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.
- •Previous treatment targeting IGF-1R.
- •Selenium and biotin must be discontinued 3 weeks prior to Screening and must not be restarted during the trial; however, taking a multivitamin that includes selenium and/or biotin is allowed.
- •Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.
- •Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.
- •Malignant condition in the past 5 years before signing the ICF (except successfully treated basal/squamous cell carcinoma of the skin).
- •Acute cardiovascular disease history or treatment within 6 months before the first dose.
- •Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
- •Pregnant or lactating women.
- •Drug or alcohol abuse during the screening period.
- •Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.
- •Biopsy-proven or clinically suspected inflammatory bowel disease.
- •Positive results for serum virology tests (defined as pos
- •Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.
- •Subjects who underwent major surgery within 4 weeks before the first dose or are expected to undergo surgery during the study period or within 4 weeks after the study.
- •Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.
Investigators
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