A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Study Purpose

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.

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:

- Male or female participants with chronic plaque psoriasis (greater than or equal to 10 percent (%) body surface area (BSA); static Physician's Global Assessment (sPGA) score of greater than or equal to 3 and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12) at least 6 months before baseline - Have a body mass index between 18 and 35 kilogram per meter square (kg/m²)

Exclusion Criteria:

- Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists - Have an active or recent infection or a compromised immune system - Have active or dormant tuberculosis - Have a serious or unstable/uncontrolled illness, including heart disease, abnormal blood pressure, mental disorder, malignancy or other disease - Be pregnant or breastfeeding - Had any major surgery within 8 weeks prior to baseline

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.

NCT03073213
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 1
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.

Psoriasis

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

Changsha, Hunan, China

Status

Recruiting

Address

Xiangya Hospital, Central South University

Changsha, Hunan,

Site Contact

13975855322

Hangzhou, Zhejiang, China

Status

Recruiting

Address

Second Affiliate Hospital of Zhejiang Medical University

Hangzhou, Zhejiang, 310009

Site Contact

865717783858

Shanghai, China

Status

Recruiting

Address

Ruijin Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, , 200025

Site Contact

8618917762309

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