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Clinical Trials in China / NCT07211776
Active, not recruiting Phase 3

A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease

NCT07211776 · tracked via the Priya Life Science China tracker
Sponsor
Zai Lab (Shanghai) Co., Ltd
Phase
Phase 3
Started
2025-12-05
Last updated
2026-09-09

Condition(s) studied

Thyroid Eye Disease (TED)

Investigational drug(s) / intervention(s)

ZL-1109 (VRDN-003) →Placebo

ZL-1109 (VRDN-003): ZL-1109 subcutaneous injection

Placebo: Matching placebo subcutaneous injection

Study summary

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 \[without a corresponding increase of ≥2 mm in the fellow eye\]

Trial sites (26)

FacilityCityRegionStatus
Site01006 Beijing China
Site01009 Beijing China
Site01010 Beijing China
Site01029 Bengbu China
Site01020 Changsha China
Site01022 Chengdu China
Site01031 Chongqing China
Site01011 Dalian China
Site01008 Foshan China
Site01004 Fuzhou China
Site01007 Guangzhou China
Site01027 Guiyang China
Site01018 Hangzhou China
Site01002 Hefei China
Site01024 Jinan China
Site01005 Luoyang China
Site01017 Nanchang China
Site01001 Shanghai China
Site01012 Shenyang China
Site01023 Taiyuan China
Site01013 Tianjin China
Site01016 Wuxi China
Site01028 Xi'an China
Site01026 Yangzhou China
Site01019 Zhengzhou China
Site01030 Zhengzhou China

More Zai Lab (Shanghai) Co., Ltd. trials in China

A Study of ZL-1310 in Participants With Selected Solid Tumors Recruiting
A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE) Recruiting
Phase 1a/b Study of ZL-6201 Safety, PK, and Preliminary Efficacy in Sarcoma and Selected Tumors Recruiting
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis Recruiting
A Study of ZL-1310 in Subjects With Small Cell Lung Cancer Recruiting

Other trials for the same condition

A Study of GenSci098 in Subjects With Active Thyroid Eye Disease Recruiting
Open-Label Extension Study of MHB018A in Subjects With Thyroid Eye Disease Recruiting
MHB018A Treatment in Patients With Chronic Thyroid Eye Disease Active, not recruiting
Official registry record

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.

View NCT07211776 on ClinicalTrials.gov ↗ ← All trials in China