Status:
COMPLETED
A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline.
- Have ≥10% BSA involvement at screening and baseline.
- Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.
- Are candidates for phototherapy and/or systemic therapy.
Exclusion
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
- Drug-induced psoriasis.
- Ongoing use of prohibited treatments.
- Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor.
- Have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to baseline, whichever is longer.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2020
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT03364309
Start Date
April 26 2018
End Date
June 4 2020
Last Update
June 25 2021
Active Locations (17)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
Guangdong Province People's Hospital
Guangzhou, Guangdong, China, 510080
4
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011