RecruitingPhase 3NCT07211776
A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease
A Multicenter, Double-blinded, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ZL-1109 in Chinese Participants With Thyroid Eye Disease (TED)
Sponsor
Zai Lab (Shanghai) Co., Ltd.
Enrollment
99 participants
Start Date
Dec 5, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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
Exclusion Criteria4
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGZL-1109 (VRDN-003)
ZL-1109 subcutaneous injection
DRUGPlacebo
Matching placebo subcutaneous injection
Locations(27)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07211776