MHB018A Treatment in Patients With Chronic Thyroid Eye Disease (NCT07257185) | Clinical Trial Compass
RecruitingPhase 3
MHB018A Treatment in Patients With Chronic Thyroid Eye Disease
China150 participantsStarted 2026-03-17
Plain-language 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 chronic TED.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
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.