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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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  • - Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03364309
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking University Peoples Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Peoples Hospital

Beijing, Beijing, 100044

Site Contact

861088325965

Peking University Third Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University Third Hospital

Beijing, Beijing, 100191

Site Contact

15611963048

Guangdong Province People's Hospital, Guangzhou, Guangdong, China

Status

Recruiting

Address

Guangdong Province People's Hospital

Guangzhou, Guangdong, 510080

Site Contact

8613825153421

Changsha, Hunan, China

Status

Recruiting

Address

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011

Site Contact

8613787097676

YanCheng First People's Hospital, Yancheng, Jiangsu, China

Status

Recruiting

Address

YanCheng First People's Hospital

Yancheng, Jiangsu, 224005

Site Contact

8651588508662

Changchun City, Jilin, China

Status

Recruiting

Address

No.2 Hospital Affiliated to Jilin University

Changchun City, Jilin, 130041

Site Contact

8643188796114

Shenyang, Liaoning, China

Status

Recruiting

Address

The First Hospital of China Medical University

Shenyang, Liaoning, 110001

Site Contact

862483282525

Nanjing, Nanjing, China

Status

Recruiting

Address

The First Affiliated Hospital with Nanjing Medical Universit

Nanjing, Nanjing, 210029

Site Contact

862568136541

Xi'an, Shaanxi, China

Status

Recruiting

Address

Second Affiliate Hospital of Medical College of Xi'an Jiaoto

Xi'an, Shaanxi, 710004

Site Contact

362987678326

Tai Yuan, Shan XI, China

Status

Recruiting

Address

1st affiliated Hospital of Shanxi Medical University

Tai Yuan, Shan XI, 030001

Site Contact

8618503519388

Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041

Site Contact

8618980601691

Hangzhou, Zhejiang, China

Status

Recruiting

Address

Second Affiliate Hospital of Zhejiang Medical University

Hangzhou, Zhejiang, 310009

Site Contact

8613906520296

Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014

Site Contact

8613858039503

Beijing Chao Yang Hospital, Beijing, China

Status

Recruiting

Address

Beijing Chao Yang Hospital

Beijing, , 100020

Site Contact

8601085231850

Peking University First Hospital, Beijing, China

Status

Recruiting

Address

Peking University First Hospital

Beijing, , 100034

Site Contact

8613301152845

Shanghai, China

Status

Recruiting

Address

Ruijin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, , 200025

Site Contact

8618917762309

Shanghai, China

Status

Recruiting

Address

Shanghai Changhai Hospital, The 2nd Military Medical Univ.

Shanghai, ,

Site Contact

8618930939371

Shanghai Dermatology Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Dermatology Hospital

Shanghai, ,

Site Contact

02161833137

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