Clinical trial NCT03364309: A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis
ixekizumab
skin condition
skin disease
itching
psoriasis vulgaris
immune-mediated systemic disease
skin lesions
scaly patches
papules
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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* Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the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.

Primary outcomes:
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
timeFrame: Week 12
measure: Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)
timeFrame: Week 12
measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
timeFrame: Week 12
measure: Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
timeFrame: Week 12
measure: Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4
timeFrame: Week 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline, Week 12
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement
timeFrame: Baseline, Week 12
measure: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis
timeFrame: Baseline, Week 12
measure: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement
timeFrame: Baseline, Week 12
measure: Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Week 12
measure: Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score
timeFrame: Baseline, Week 12
measure: Change From Baseline on Patient Global Assessment of Disease Severity
timeFrame: Baseline, Week 12
measure: Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Joint Pain Visual Analog Scale (VAS)
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Anti-Ixekizumab Antibodies
timeFrame: Baseline through Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Province People's Hospital
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Yancheng
country: China
facility: YanCheng First People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Nanjing
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shan XI
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Second Affiliate Hospital of Zhejiang Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: