Actively Recruiting
A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease
Led by Zai Lab (Shanghai) Co., Ltd. · Updated on 2025-12-29
99
Participants Needed
27
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have moderate to severe Thyroid Eye Disease
- Meet clinical diagnosis criteria for active Thyroid Eye Disease
- Agree to use highly effective contraception as required by the protocol
- Female participants must have a negative serum pregnancy test at screening
You will not qualify if you...
- Prior treatment with anti-IGF-1R or anti-TSHR monoclonal antibodies
- Recent use of systemic corticosteroids, steroid eye drops, immunosuppressive drugs, or radioactive iodine treatment before first dose
- Corneal decompensation in the study eye that does not respond to medical management
- Pre-existing eye conditions in the study eye that could affect study results, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Site01006
Beijing, China
Not Yet Recruiting
2
Site01009
Beijing, China
Actively Recruiting
3
Site01010
Beijing, China
Not Yet Recruiting
4
Site01029
Bengbu, China
Not Yet Recruiting
5
Site01020
Changsha, China
Not Yet Recruiting
6
Site01022
Chengdu, China
Not Yet Recruiting
7
Site01031
Chongqing, China
Actively Recruiting
8
Site01011
Dalian, China
Not Yet Recruiting
9
Site01008
Foshan, China
Actively Recruiting
10
Site01004
Fuzhou, China
Actively Recruiting
11
Site01007
Guangzhou, China
Actively Recruiting
12
Site01027
Guiyang, China
Actively Recruiting
13
Site01018
Hangzhou, China
Not Yet Recruiting
14
Site01002
Hefei, China
Actively Recruiting
15
Site01024
Jinan, China
Actively Recruiting
16
Site01005
Luoyang, China
Actively Recruiting
17
Site01017
Nanchang, China
Not Yet Recruiting
18
Site01001
Shanghai, China
Actively Recruiting
19
Site01012
Shenyang, China
Not Yet Recruiting
20
Site01023
Taiyuan, China
Not Yet Recruiting
21
Site01013
Tianjin, China
Not Yet Recruiting
22
Site01016
Wuxi, China
Not Yet Recruiting
23
Site01028
Xi'an, China
Not Yet Recruiting
24
Site01025
Xuzhou, China
Not Yet Recruiting
25
Site01026
Yangzhou, China
Not Yet Recruiting
26
Site01019
Zhengzhou, China
Not Yet Recruiting
27
Site01030
Zhengzhou, China
Not Yet Recruiting
Research Team
Z
ZL-1109-002 Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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