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A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.
Study I1F-MC-RHBH is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study examining the effect of 2 dose regimens of ixekizumab versus placebo in participants with moderate-to-severe plaque psoriasis (Ps) during an induction dosing period with dosing for 12 weeks and the primary endpoint measured at 12 weeks, followed by a randomized, 48-week maintenance dosing period. During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse or rebound following treatment withdrawal, and response to retreatment following relapse.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Guangdong Province People's Hospital
Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
YanCheng First People's Hospital
Yancheng, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Nanjing, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Start Date
April 26, 2018
Primary Completion Date
June 4, 2020
Completion Date
June 4, 2020
Last Updated
June 25, 2021
438
ACTUAL participants
Ixekizumab
DRUG
Placebo
DRUG
Lead Sponsor
Eli Lilly and Company
NCT07116967
NCT07250802
NCT07449702
Data Source & Attribution
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