ZL-1109 for active moderate-to-severe thyroid eye disease in Chinese participants.

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)

We will test whether ZL-1109 helps Chinese patients with active moderate-to-severe thyroid eye disease more than a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zai Lab (Hong Kong), Ltd. (Industry-sponsored)
• Locations: 27 sites (Beijing and 26 other locations)
• Trial ID: NCT07211776 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study comparing ZL-1109 to placebo in Chinese participants with active moderate-to-severe thyroid eye disease. After a screening period of up to 28 days, participants enter a 24-week double-blind randomized period and may enter an extension phase that totals 52 weeks (or 70 weeks for some who receive open-label treatment). The trial will monitor measures of efficacy, safety, and tolerability throughout dosing and follow-up. Key exclusions include prior anti-IGF-1R or anti-TSHR antibody treatment, recent systemic steroids or other immunosuppressives, radioactive iodine within a specified window, and certain ocular conditions such as unresponsive corneal decompensation.

Who should consider this trial

Good fit: Adults in China with active moderate-to-severe TED who meet diagnostic criteria, agree to use effective contraception as required, and have not recently received prohibited immunosuppressive or targeted antibody therapies are ideal candidates.

Not a fit: Patients with unresponsive corneal decompensation, pre-existing ocular conditions that would confound results, prior anti-IGF-1R or anti-TSHR antibody treatment, or recent systemic steroids/RAI are excluded and unlikely to benefit from or be eligible for this study.

Why it matters

Potential benefit: If successful, ZL-1109 could reduce eye inflammation and improve symptoms and appearance for people with active TED.

How similar studies have performed: Other anti-IGF-1R therapies (for example, teprotumumab) have shown clinical benefit in TED, so the mechanism has prior positive evidence.

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.

Where this trial is running

Beijing and 26 other locations

• Site01006 — Beijing, China (Not_yet_recruiting)
• Site01009 — Beijing, China (Recruiting)
• Site01010 — Beijing, China (Not_yet_recruiting)
• Site01029 — Bengbu, China (Not_yet_recruiting)
• Site01020 — Changsha, China (Not_yet_recruiting)
• Site01022 — Chengdu, China (Not_yet_recruiting)
• Site01031 — Chongqing, China (Recruiting)
• Site01011 — Dalian, China (Not_yet_recruiting)
• Site01008 — Foshan, China (Recruiting)
• Site01004 — Fuzhou, China (Recruiting)
• Site01007 — Guangzhou, China (Recruiting)
• Site01027 — Guiyang, China (Recruiting)
• Site01018 — Hangzhou, China (Not_yet_recruiting)
• Site01002 — Hefei, China (Recruiting)
• Site01024 — Jinan, China (Recruiting)
• Site01005 — Luoyang, China (Recruiting)
• Site01017 — Nanchang, China (Not_yet_recruiting)
• Site01001 — Shanghai, China (Recruiting)
• Site01012 — Shenyang, China (Not_yet_recruiting)
• Site01023 — Taiyuan, China (Not_yet_recruiting)
• Site01013 — Tianjin, China (Not_yet_recruiting)
• Site01016 — Wuxi, China (Not_yet_recruiting)
• Site01028 — Xi'an, China (Not_yet_recruiting)
• Site01025 — Xuzhou, China (Not_yet_recruiting)
• Site01026 — Yangzhou, China (Not_yet_recruiting)
• Site01019 — Zhengzhou, China (Not_yet_recruiting)
• Site01030 — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: ZL-1109-002 Study Team

Conditions Thyroid Eye Disease