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

Not Applicable

Not yet recruiting

• Conditions: Thyroid Eye Disease (TED)
• Interventions: Drug: ZL-1109 (VRDN-003); Drug: Placebo

• Registration Number: NCT07211776
• Lead Sponsor: Zai Lab (Shanghai) Co., Ltd.

Brief Summary

A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)

Detailed Description

This is a multicenter, Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety and tolerability of ZL-1109 in participants with active TED. The study will comprise of a screening period of up to 28 days, a double-blinded randomized placebo-controlled period of 24 weeks and an extension period. For responders and non-responders who do not want to receive open-label treatment, the the study period is 52 weeks from the first dose. For non-responders who consent to and are considered eligible to receive open-label treatment, the study period is 70 weeks from the first dose.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Study Start: 2025-12-27
• Primary Completion: 2027-03-14
• Study Completion: 2028-01-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized controlled period: ZL-1109 every 4 weeks	ZL-1109 (VRDN-003)	Participants will receive ZL-1109 per protocol defined dosing regimen.
Randomized controlled period: ZL-1109 every 8 weeks	ZL-1109 (VRDN-003)	Participants will receive ZL-1109 and placebo per protocol defined dosing regimen.
Randomized controlled period: ZL-1109 every 8 weeks	Placebo	Participants will receive ZL-1109 and placebo per protocol defined dosing regimen.
Randomized controlled period: Placebo every 4 weeks	Placebo	Participants will receive placebo per protocol defined dosing regimen.
OLE treatment period: ZL-1109 every 4 weeks	ZL-1109 (VRDN-003)	Participants who not responded would receive ZL-1109 per protocol defined dosing regimen.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in proptosis in the study eye	At Week 24	Change from baseline in proptosis in the study eye
Overall 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 \[without a corresponding increase of ≥2 mm in the fellow eye\]) AND ≥ 2 points reduction in CAS from baseline in the study eye \[without a corresponding increase of ≥2 points in the fellow eye\]
Change from baseline in Clinical Activity Score (CAS) in the study eye	At Week 24	Change from baseline in CAS in the study eye \[range, 0 to 7, with higher scores indicating greater level of inflammation\]
Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye	At Week 24	Proportion of participants with a CAS of 0 or 1 in the study eye
Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0	At Week 24	Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0)
Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0	At Week 24	Proportion of participants with a reduction in Diplopia Score to 0 from baseline (for participants with baseline Diplopia Score greater than 0)
Clinical Activity Responder Rate in the study eye	At Week 24	Clinical Activity Responder Rate in the study eye (i.e., ≥ 2 points reduction in CAS from baseline in the study eye \[without a corresponding increase of ≥2 points in the fellow eye\])

Trial Locations

Locations (27)

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

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