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A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Ixekizumab

Placebo

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring plaque psoriasis, ixekizumab, skin condition, skin disease, itching, psoriasis vulgaris, immune-mediated systemic disease, skin lesions, scaly patches, papules

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the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

Sites / Locations

Peking University People's Hospital
Peking University Third Hospital
Guangdong Province People's Hospital
The Second Xiangya Hospital of Central South University
YanCheng First People's Hospital
The Second Hospital of Jilin University
The First Hospital of China Medical University
The First Affiliated Hospital with Nanjing Medical University
The Second Affiliated Hospital of Xi'an Jiaotong University
First Hospital of Shanxi Medical University
West China Hospital of Sichuan University
Second Affiliate Hospital of Zhejiang Medical University
Zhejiang Provincial People's Hospital
Beijing Chao Yang Hospital
Peking University First Hospital
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai Dermatology Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Ixekizumab 80mg Q4W

Ixekizumab 80mg Q2W

Placebo

Arm Description

Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period.

Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period.

Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.

Outcomes

Primary Outcome Measures

Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.

Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Secondary Outcome Measures

Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.

Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life. Least Square Mean (LS Mean) was calculated using Mixed Model Repeated Measures (MMRM) model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement

NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis

The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement

The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score

Change From Baseline on Patient Global Assessment of Disease Severity

The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement

The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Change From Baseline on the Joint Pain Visual Analog Scale (VAS)

The Joint Pain VAS is a participant-administered scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of a participant's joint pain from PsA is indicated by placing a single mark on the horizontal scale (0 = none; 100 = as severe as you can imagine). LS Mean was calculated using MMRM model includes treatment, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

Percentage of Participants With Anti-Ixekizumab Antibodies

Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.

Full Information

NCT ID

NCT03364309

First Posted

November 9, 2017

Last Updated

June 3, 2021

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03364309

Brief Title

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

2. Study Status

Record Verification Date

June 1, 2021

Overall Recruitment Status

Completed

Study Start Date

April 26, 2018 (Actual)

Primary Completion Date

June 4, 2020 (Actual)

Study Completion Date

June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

Keywords

plaque psoriasis, ixekizumab, skin condition, skin disease, itching, psoriasis vulgaris, immune-mediated systemic disease, skin lesions, scaly patches, papules

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

438 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ixekizumab 80mg Q4W

Arm Type

Experimental

Arm Description

Participants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period.

Arm Title

Ixekizumab 80mg Q2W

Arm Type

Experimental

Arm Description

Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.

Intervention Type

Drug

Intervention Name(s)

Ixekizumab

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement

Description

Time Frame

Week 12

Title

Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)

Description

The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.

Time Frame

Week 12

Title

Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

Description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Time Frame

Week 12

Title

Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

Description

The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).

Time Frame

Week 12

Title

Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4

Description

Time Frame

Week 12

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants With Baseline Fingernail Involvement

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants With Baseline Scalp Involvement

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline on Patient Global Assessment of Disease Severity

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Palmoplantar PASI (PPASI) in Participants With Baseline Palmoplantar Involvement

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline on the Joint Pain Visual Analog Scale (VAS)

Description

Time Frame

Baseline, Week 12

Title

Percentage of Participants With Anti-Ixekizumab Antibodies

Description

Time Frame

Baseline through Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Peking University People's Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Peking University Third Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

Facility Name

Guangdong Province People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

The Second Xiangya Hospital of Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

Facility Name

YanCheng First People's Hospital

City

Yancheng

State/Province

Jiangsu

ZIP/Postal Code

224005

Country

China

Facility Name

The Second Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130022

Country

China

Facility Name

The First Hospital of China Medical University

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Facility Name

The First Affiliated Hospital with Nanjing Medical University

City

Nanjing

State/Province

Nanjing

ZIP/Postal Code

210029

Country

China

Facility Name

The Second Affiliated Hospital of Xi'an Jiaotong University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710004

Country

China

Facility Name

First Hospital of Shanxi Medical University

City

Taiyuan

State/Province

Shan XI

ZIP/Postal Code

030001

Country

China

Facility Name

West China Hospital of Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Second Affiliate Hospital of Zhejiang Medical University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Name

Zhejiang Provincial People's Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

Facility Name

Beijing Chao Yang Hospital

City

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

Peking University First Hospital

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Ruijin Hospital Affiliated to Shanghai Jiao Tong University

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Shanghai Dermatology Hospital

City

Shanghai

ZIP/Postal Code

200443

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

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