NCT06989918 MHB018A Treatment in Patients With Active Thyroid Eye Disease
| NCT ID | NCT06989918 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Minghui Pharmaceutical (Hangzhou) Ltd |
| Condition | Thyroid Associated Ophthalmopathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2026-07-31 |
Trial Parameters
Eligibility Fast-Check
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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 the treatment of participants suffering from active TED.
Eligibility Criteria
Inclusion Criteria: 1. Subjects voluntarily participating in the study and signing the informed consent form; 2. Aged 18-75 years (inclusive), of any gender; 3. 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). 4. Subjects with a clinical diagnosis of moderate to severe TED at screening and baseline. 5. Does not require immediate surgical ophthalmological intervention, and no corrective surgery/orbital radiotherapy is planned during the study. 6. Diabetic subjects must have well-controlled stable disease. 7. Sufficient bone marrow and organ function. 8. 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. 9. Subject is willing and able