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

NCT ID: NCT07211776

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-05

Study Completion Date

2028-01-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Thyroid Eye Disease (TED)

Keywords

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Thyroid Eye Disease (TED)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to one of the three study arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants, Investigator, Outcomes Assessor and Sponsor will be masked.

Study Groups

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Randomized controlled period: ZL-1109 every 4 weeks

Participants will receive ZL-1109 per protocol defined dosing regimen.

Group Type EXPERIMENTAL

ZL-1109 (VRDN-003)

Intervention Type DRUG

ZL-1109 subcutaneous injection

Randomized controlled period: ZL-1109 every 8 weeks

Participants will receive ZL-1109 and placebo per protocol defined dosing regimen.

Group Type EXPERIMENTAL

ZL-1109 (VRDN-003)

Intervention Type DRUG

ZL-1109 subcutaneous injection

Placebo

Intervention Type DRUG

Matching placebo subcutaneous injection

Randomized controlled period: Placebo every 4 weeks

Participants will receive placebo per protocol defined dosing regimen.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo subcutaneous injection

OLE treatment period: ZL-1109 every 4 weeks

Participants who not responded would receive ZL-1109 per protocol defined dosing regimen.

Group Type OTHER

ZL-1109 (VRDN-003)

Intervention Type DRUG

ZL-1109 subcutaneous injection

Interventions

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ZL-1109 (VRDN-003)

ZL-1109 subcutaneous injection

Intervention Type DRUG

Placebo

Matching placebo subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zai Lab (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site01006

Beijing, , China

Site Status NOT_YET_RECRUITING

Site01009

Beijing, , China

Site Status RECRUITING

Site01010

Beijing, , China

Site Status NOT_YET_RECRUITING

Site01029

Bengbu, , China

Site Status NOT_YET_RECRUITING

Site01020

Changsha, , China

Site Status NOT_YET_RECRUITING

Site01022

Chengdu, , China

Site Status NOT_YET_RECRUITING

Site01031

Chongqing, , China

Site Status RECRUITING

Site01011

Dalian, , China

Site Status NOT_YET_RECRUITING

Site01008

Foshan, , China

Site Status RECRUITING

Site01004

Fuzhou, , China

Site Status RECRUITING

Site01007

Guangzhou, , China

Site Status RECRUITING

Site01027

Guiyang, , China

Site Status RECRUITING

Site01018

Hangzhou, , China

Site Status NOT_YET_RECRUITING

Site01002

Hefei, , China

Site Status RECRUITING

Site01024

Jinan, , China

Site Status RECRUITING

Site01005

Luoyang, , China

Site Status RECRUITING

Site01017

Nanchang, , China

Site Status NOT_YET_RECRUITING

Site01001

Shanghai, , China

Site Status RECRUITING

Site01012

Shenyang, , China

Site Status NOT_YET_RECRUITING

Site01023

Taiyuan, , China

Site Status NOT_YET_RECRUITING

Site01013

Tianjin, , China

Site Status NOT_YET_RECRUITING

Site01016

Wuxi, , China

Site Status NOT_YET_RECRUITING

Site01028

Xi'an, , China

Site Status NOT_YET_RECRUITING

Site01025

Xuzhou, , China

Site Status NOT_YET_RECRUITING

Site01026

Yangzhou, , China

Site Status NOT_YET_RECRUITING

Site01019

Zhengzhou, , China

Site Status NOT_YET_RECRUITING

Site01030

Zhengzhou, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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ZL-1109-002 Study Team

Role: CONTACT

Phone: 86 021-61632588

Email: [email protected]

Other Identifiers

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ZL-1109-002

Identifier Type: -

Identifier Source: org_study_id