NCT07211776 A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease
| NCT ID | NCT07211776 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zai Lab (Shanghai) Co., Ltd. |
| Condition | Thyroid Eye Disease (TED) |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2027-03-14 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
Eligibility Criteria
Key Inclusion Criteria: 1. Have moderate to severe TED 2. Must meet the clinical diagnosis criteria of active TED 3. Must agree to use highly effective contraception as specified in the protocol 4. Female TED participants must have a negative serum pregnancy test at screening Key Exclusion Criteria: 1. Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb. 2. Have received systemic corticosteroids or steroid eye drops for any condition, or other immunosuppressive drugs for any condition, including TED, or radioactive iodine (RAI) treatment within a certain period prior to first dose. 3. Have corneal decompensation in the study eye unresponsive to medical management. 4. Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.