Status:
RECRUITING
MHB018A Treatment in Patients With Active Thyroid Eye Disease
Lead Sponsor:
Minghui Pharmaceutical (Hangzhou) Ltd
Conditions:
Thyroid Associated Ophthalmopathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 th...
Detailed Description
The percentage of subjects with a reduction in proptosis of ≥2 mm in the study eye/target eye compared to baseline, without deterioration (≥2 mm) in the fellow eye.
Eligibility Criteria
Inclusion
- Subjects voluntarily participating in the study and signing the informed consent form;
- Aged 18-75 years (inclusive), of any gender;
- Clinical diagnosis of active Thyriod Eye Disease (TED). The Clinical Activity Score (CAS) of the study eye/target eye at screening and baseline must be ≥3 points (7-point scale).
- 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
- 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.
Key Trial Info
Start Date :
July 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06989918
Start Date
July 22 2025
End Date
July 31 2028
Last Update
November 19 2025
Active Locations (1)
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1
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 201419