About this trial
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
Eligibility criteria
Qualifiers
Subjects voluntarily participating in the study and signing the informed consent form;
Aged 18-75 years (inclusive), of any gender;
Completed the 24-week double-blind treatment period in either the MHB018A-P-301 or MHB018A-P-302 study, and within 28 days after Week 24 visit of the previous study when enrolled in this OLE study (does not apply to subjects who meet the relapse criteria during the safety follow-up period).
Proptosis non-responder at Week 24 visit in the double-blind treatment period of either the MHB018A-P-301 or MHB018A-P-302 study (defined as a <2 mm reduction from baseline in the study eye, or a ≥2 mm reduction in the study eye accompanied by a ≥2 mm worsening from baseline in proptosis of the fellow eye), and/or who meet the retreatment criteria for relapse during the safety follow-up period.
Disqualifiers
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.
Free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal reference range at screening.
Received any treatment for TED, intravenous corticosteroids, immunosuppressive agents, investigational drug from the last visit of the MHB018A-P-301 or MHB018A-P-302 trial until participation in this study.
Trial design
Treatments tested in this trial
- MHB018A injection