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)

What this Trial Is About

Researchers are conducting a multicenter, Phase 3, randomized, double-blinded, placebo-controlled trial to study the effects of ZL-1109 on Chinese participants with active Thyroid Eye Disease (TED). This study aims to assess the efficacy, safety, and tolerability of ZL-1109 in improving symptoms of TED, a condition that affects the eyes. The trial is sponsored by Zai Lab (Shanghai) Co., Ltd. and focuses on participants aged 18 to 75 years with moderate to severe and active TED. Participants will be randomly assigned to receive either ZL-1109 or a matching placebo through subcutaneous injections. The study includes a screening period of up to 28 days, followed by a 24-week double-blinded treatment period. After this, participants may enter an extension phase, lasting either up to 52 weeks for those who decline open-label treatment or up to 70 weeks for those who agree to receive open-label ZL-1109 if they do not respond initially. Dosing regimens vary, with ZL-1109 given every 4 or 8 weeks during the randomized period and every 4 weeks during the open-label extension. Throughout the trial, participants will undergo assessments including measurement of proptosis (eye bulging), Clinical Activity Score (CAS), and diplopia (double vision) responses at Week 24. Researchers will monitor treatment safety and tolerability, with follow-up visits during the extension period. The total participation duration depends on response status and consent to open-label treatment, ensuring detailed evaluation of outcomes and safety over an extended timeframe.

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