Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease
This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED.
| Condition(s) | Thyroid Eye Disease (TED) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a multicenter, open-label extension (OLE) study of MHB018A in subjects with moderate-to-severe TED. |
| Who can participate | 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. 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). 4. 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 cr |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Minghui Pharmaceutical (Hangzhou) Ltd |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2026-01-09 |
| NCT ID | NCT07262476 |
| Official listing | https://clinicaltrials.gov/study/NCT07262476 |