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

Phase 3Active Not RecruitingNCT07211776

Zai Lab (Shanghai) Co., Ltd.108 enrolled

Overview

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

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 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 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

108

Conditions

Thyroid Eye Disease (TED)

Interventions

ZL-1109 (VRDN-003)DRUG

ZL-1109 subcutaneous injection

PlaceboDRUG

Matching placebo subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (26)

Site01006

Beijing, China

Site01009

Beijing, China

Outcomes

Primary Outcomes

Proptosis Responder Rate in the study eye

Proportion of participants with a ≥2 mm reduction from baseline in proptosis in the study eye \[without a corresponding increase of ≥2 mm in the fellow eye\]

Time frame: At Week 24

Secondary Outcomes

Change from baseline in proptosis in the study eye

Time frame: At Week 24

Overall Responder Rate in the study eye

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

Time frame: At Week 24

Change from baseline in Clinical Activity Score (CAS) in the study eye

Change from baseline in CAS in the study eye \[range, 0 to 7, with higher scores indicating greater level of inflammation\]

Time frame: At Week 24

Proportion of participants with a Clinical Activity Score (CAS) of 0 or 1 in the study eye

Proportion of participants with a CAS of 0 or 1 in the study eye

Time frame: At Week 24

Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0

Proportion of participants with a reduction in Diplopia Score of ≥1 from baseline (for participants with baseline Diplopia Score greater than 0)

Time frame: At Week 24

Diplopia Resolution Rate for participants with baseline Diplopia Score greater than 0

Data from ClinicalTrials.gov

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