Treatment of Active Thyroid Eye Disease With MHB018A in a Randomized, Placebo-Controlled Study

Exclusion Criteria

• •1. 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.
• •2. Corneal decompensation unresponsive to medical management.
• •3. Decrease in CAS of ≥ 2 points or decrease in proptosis of ≥ 2 mm between screening and baseline.
• •4. Free thyroxine (FT4) and free triiodothyronine (FT3) levels \<50% above or below the normal reference range at screening.
• •5. Subjects who have previously received orbital radiotherapy or ophthalmic surgery for TED.
• •6. 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.
• •7. Subjects who used oral or intravenous corticosteroids for reasons other than TED within 4 weeks prior to Screening, excluding local use (topical, nasal, inhalation).
• •8. Any previous treatment with rituximab, tocilizumab, other immunosuppressive agent use within 3 months prior to Screening.
• •9. Previous treatment targeting IGF-1R.
• •10. 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.
• •11. Use of an investigational agent for any condition within 30 days prior to Screening or anticipated use during the course of the trial.
• •12. Identified pre-existing ophthalmic disease that, in the judgment of the Investigator, would preclude study participation or complicate interpretation of study results.
• •13. Malignant condition in the past 5 years before signing the ICF (except successfully treated basal/squamous cell carcinoma of the skin).
• •14. Acute cardiovascular disease history or treatment within 6 months before the first dose.
• •15. Presence of poorly controlled hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg; Renal artery stenosis.
• •16. Pregnant or lactating women.
• •17. Drug or alcohol abuse during the screening period.
• •18. Hearing impairment history in either ear during the screening period; or abnormal pure tone audiometry results.
• •19. Biopsy-proven or clinically suspected inflammatory bowel disease.
• •20. Positive results for serum virology tests (defined as pos
• •21. Subjects who received or planned to receive live or attenuated live vaccines within 4 weeks before the first dose or during the study period.
• •22. 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.
• •23. Known hypersensitivity to any of the components of MNB018A or prior hypersensitivity reactions to mAbs.