Status:
RECRUITING
A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease
Lead Sponsor:
Zai Lab (Shanghai) Co., Ltd.
Conditions:
Thyroid Eye Disease (TED)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
Detailed Description
This is a multicenter, Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZL-1109 in participants with active TED. The study will compri...
Eligibility Criteria
Inclusion
- Key
- Have moderate to severe TED
- Must meet the clinical diagnosis criteria of active TED
- Must agree to use highly effective contraception as specified in the protocol
- Female TED participants must have a negative serum pregnancy test at screening
- Key
Exclusion
- Have received prior treatment with another anti-IGF-1R mAb or anti-thyroid stimulating hormone receptor (TSHR) mAb.
- 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.
- Have corneal decompensation in the study eye unresponsive to medical management.
- Have a pre-existing ophthalmic in the study eye which in the opinion of the Investigator, would confound interpretation of the study results.
Key Trial Info
Start Date :
December 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2028
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT07211776
Start Date
December 5 2025
End Date
January 29 2028
Last Update
December 29 2025
Active Locations (27)
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1
Site01006
Beijing, China
2
Site01009
Beijing, China
3
Site01010
Beijing, China
4
Site01029
Bengbu, China