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)
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A Multicenter, Double-blinded, Randomized, Placebo-controlled Phase 3 Study of ZL-1109 in Chinese Participants with Thyroid Eye Disease (TED)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Have moderate to severe TED
• Must meet the clinical diagnosis criteria of active TED
• Must agree to use highly effective contraception as specified in the protocol
• Female TED participants must have a negative serum pregnancy test at screening
Locations
Other Locations
China
Site01006
NOT_YET_RECRUITING
Beijing
Site01009
RECRUITING
Beijing
Site01010
NOT_YET_RECRUITING
Beijing
Site01029
NOT_YET_RECRUITING
Bengbu
Site01020
NOT_YET_RECRUITING
Changsha
Site01022
NOT_YET_RECRUITING
Chengdu
Site01031
RECRUITING
Chongqing
Site01011
NOT_YET_RECRUITING
Dalian
Site01008
RECRUITING
Foshan
Site01004
RECRUITING
Fuzhou
Site01007
RECRUITING
Guangzhou
Site01027
RECRUITING
Guiyang
Site01018
NOT_YET_RECRUITING
Hangzhou
Site01002
RECRUITING
Hefei
Site01024
RECRUITING
Jinan
Site01005
RECRUITING
Luoyang
Site01017
NOT_YET_RECRUITING
Nanchang
Site01001
RECRUITING
Shanghai
Site01012
NOT_YET_RECRUITING
Shenyang
Site01023
NOT_YET_RECRUITING
Taiyuan
Site01013
NOT_YET_RECRUITING
Tianjin
Site01016
NOT_YET_RECRUITING
Wuxi
Site01028
NOT_YET_RECRUITING
Xi'an
Site01025
NOT_YET_RECRUITING
Xuzhou
Site01026
NOT_YET_RECRUITING
Yangzhou
Site01019
NOT_YET_RECRUITING
Zhengzhou
Site01030
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
ZL-1109-002 Study Team
1109-002_studyteam@zailaboratory.com
86 021-61632588
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2028-01-29
Participants
Target number of participants: 99
Treatments
Experimental: Randomized controlled period: ZL-1109 every 4 weeks
Participants will receive ZL-1109 per protocol defined dosing regimen.
Experimental: Randomized controlled period: ZL-1109 every 8 weeks
Participants will receive ZL-1109 and placebo per protocol defined dosing regimen.
Placebo_comparator: Randomized controlled period: Placebo every 4 weeks
Participants will receive placebo per protocol defined dosing regimen.
Other: OLE treatment period: ZL-1109 every 4 weeks
Participants who not responded would receive ZL-1109 per protocol defined dosing regimen.
Related Therapeutic Areas
Sponsors
Leads: Zai Lab (Shanghai) Co., Ltd.