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

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ClinicalTrials.gov Identifier: NCT03364309
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Ixekizumab Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Ixekizumab Dose Schedule 1
Ixekizumab given subcutaneously (SC).
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Experimental: Ixekizumab Dose Schedule 2
Ixekizumab given SC. Placebo given SC to maintain blind.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Drug: Placebo
Administered SC

Placebo Comparator: Placebo
Placebo given SC
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Proportion of Participants with a static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement from Baseline [ Time Frame: Week 12 ]
    Proportion of Participants with a sPGA score of clear (0) or minimal (1) with at least a 2 point improvement from baseline

  2. Proportion of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) from Baseline [ Time Frame: Week 12 ]
    Proportion of participants achieving a ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) from baseline


Secondary Outcome Measures :
  1. Proportion of Participants Achieving a static Physician Global Assessment (sPGA) Score of Clear (0) (Remission) [ Time Frame: Week 12 ]
    Proportion of participants achieving a sPGA score of clear (0) (remission)

  2. Proportion of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline [ Time Frame: Week 12 ]
    Proportion of participants achieving a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) from baseline

  3. Proportion of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) from Baseline [ Time Frame: Week 12 ]
    Proportion of participants achieving a 100% improvement in Psoriasis Area and Severity Index (PASI 100) from baseline

  4. Proportion of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction from Baseline for Participants who had Baseline Itch NRS ≥4 [ Time Frame: Week 12 ]
    Proportion of participants achieving an Itch NRS ≥4 point reduction from baseline for participants who had baseline Itch NRS ≥4

  5. Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in DLQI total score

  6. Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Score in Participants with Baseline Fingernail Involvement [ Time Frame: Baseline, Week 12 ]
    Change from baseline in NAPSI score in participants with baseline fingernail involvement

  7. Change from Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis [ Time Frame: Baseline, Week 12 ]
    Change from baseline in percent of BSA involvement of psoriasis

  8. Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Score in Participants with Baseline Scalp Involvement [ Time Frame: Baseline, Week 12 ]
    Change from baseline in PSSI score in participants with baseline scalp involvement

  9. Change from Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in medical outcomes study SF-36 PCS score

  10. Change from Baseline in Medical Outcomes Study SF-36 Mental Component Summary (MCS) Score [ Time Frame: Baseline, Week 12 ]
    Change from baseline in medical outcomes study SF-36 MCS score

  11. Change from Baseline on Patient Global Assessment of Disease Severity (Scale is from 0 [Clear] = no Ps to 5 [Severe]) [ Time Frame: Baseline, Week 12 ]
    Change from baseline on Patient Global Assessment of Disease Severity (scale is from 0 [clear] = no Ps to 5 [severe])

  12. Change from Baseline in Palmoplantar PASI (PPASI) in Participants with Baseline Palmoplantar Involvement [ Time Frame: Baseline, Week 12 ]
    Change from baseline in PPASI in participants with baseline palmoplantar involvement

  13. Change from Baseline on the Joint Pain Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 12 ]
    Change from baseline on the joint pain VAS

  14. Percentage of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Baseline through Week 12 ]
    Percentage of participants with anti-ixekizumab antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364309


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
China, Beijing
Peking University Peoples Hospital Recruiting
Beijing, Beijing, China, 100044
Contact    861088325965      
Principal Investigator: Jian Zhong Zhang         
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact    15611963048      
Principal Investigator: Chun Lei Zhang         
China, Guangdong
Guangdong Province People's Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact    8613825153421      
Principal Investigator: Xiu Qin Dong         
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact    8613787097676      
Principal Investigator: Qian Jin Lu         
China, Jiangsu
YanCheng First People's Hospital Recruiting
Yancheng, Jiangsu, China, 224005
Contact    8651588508662      
Principal Investigator: Dong LV         
China, Jilin
No.2 Hospital Affiliated to Jilin University Recruiting
Changchun City, Jilin, China, 130041
Contact    8643188796114      
Principal Investigator: Fuqiu Li         
China, Liaoning
The First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact    862483282525      
Principal Investigator: Xing Hua Gao         
China, Nanjing
The First Affiliated Hospital with Nanjing Medical Universit Recruiting
Nanjing, Nanjing, China, 210029
Contact    862568136541      
Principal Investigator: Yan Lu         
China, Shaanxi
Second Affiliate Hospital of Medical College of Xi'an Jiaoto Recruiting
Xi'an, Shaanxi, China, 710004
Contact    362987678326      
Principal Investigator: Song Mei Geng         
China, Shan XI
1st affiliated Hospital of Shanxi Medical University Recruiting
Tai Yuan, Shan XI, China, 030001
Contact    8618503519388      
Principal Investigator: Shuping Guo         
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact    8618980601691      
Principal Investigator: Zai Pei Guo         
China, Zhejiang
Second Affiliate Hospital of Zhejiang Medical University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact    8613906520296      
Principal Investigator: Min Zheng         
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310014
Contact    8613858039503      
Principal Investigator: Weili Pan         
China
Beijing Chao Yang Hospital Recruiting
Beijing, China, 100020
Contact    8601085231850      
Principal Investigator: Yan Ling He         
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact    8613301152845      
Principal Investigator: Ruoyu Li         
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Recruiting
Shanghai, China, 200025
Contact    8618917762309      
Principal Investigator: Jie Zheng         
Shanghai Changhai Hospital, The 2nd Military Medical Univ. Recruiting
Shanghai, China
Contact    8618930939371      
Principal Investigator: JUN GU         
Shanghai Dermatology Hospital Recruiting
Shanghai, China
Contact    02161833137      
Principal Investigator: Yangfeng Ding         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03364309     History of Changes
Other Study ID Numbers: 14438
I1F-MC-RHBH ( Other Identifier: Eli Lilly and Company )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Eli Lilly and Company:
plaque psoriasis
ixekizumab
skin condition
skin disease
itching
psoriasis vulgaris
immune-mediated systemic disease
skin lesions
scaly patches
papules

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Dermatologic Agents