A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-13

Study Completion Date

2019-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03364309

Plaque Psoriasis

COMPLETED PHASE3

Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

NCT03073200

Plaque Psoriasis

COMPLETED PHASE3

A Phase 3 Study in Participants With Moderate to Severe Psoriasis

NCT01474512

Psoriasis

COMPLETED PHASE3

A Study in Participants With Moderate to Severe Psoriasis

NCT01107457

Psoriasis

COMPLETED PHASE2

A Study in Japanese Participants With Moderate-to-Severe Psoriasis

NCT01624233

Psoriasis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ixekizumab single dose

Participants received single dose of 80mg Ixekizumab by subcutaneous injection.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered as subcutaneous (SC) injection

Ixekizumab Multiple Regimen 1 (80mg Q2W)

Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered as subcutaneous (SC) injection

Ixekizumab Multiple Regimen 2 (80mg Q4W)

Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.

Group Type EXPERIMENTAL

Ixekizumab

Intervention Type DRUG

Administered as subcutaneous (SC) injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ixekizumab

Administered as subcutaneous (SC) injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY2439821

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males or females aged ≥18 years.
* Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.
* Candidates for phototherapy and/or systemic therapy.
* ≥10% body surface area (BSA) involvement at screening and baseline.
* static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.

Exclusion Criteria

* Clinically significant flare of psoriasis during the 12 weeks before baseline.
* Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .
* Current or recent use of any biologic agent within the required washout periods.
* Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No