A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proptosis Responder Rate in the study eye — At Week 24 Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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