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COMPLETEDPHASE3

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis

NCT02513550•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

Detailed Description

The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Present with chronic plaque psoriasis for at least 6 months prior to enrollment
•At least 10% BSA of psoriasis at screening and at enrollment
•sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
•Candidates for phototherapy and/or systemic therapy
•Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment

Exclusion Criteria

•Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
•History of drug-induced psoriasis
•Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
•Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
•Concurrent or recent use of any biologic agent
•Have participated in any study with ixekizumab
•Received a live vaccination within 12 weeks prior to enrollment
•Serious disorder or illness other than psoriasis
•Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
•Major surgery within 8 weeks of baseline, or will require surgery during the study
+1 more criteria

Locations (125)

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

David Stoll, M.D.

Beverly Hills, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Center for Dermatology and Laser Surgery

Sacramento, California, United States

Medical Center for Clinical Research

San Diego, California, United States

University Clinical Trials, Inc.

San Diego, California, United States

Clinical Science Institute

Santa Monica, California, United States

Cherry Creek Research, Inc

Denver, Colorado, United States

Florida Academic Dermatology Centers

Coral Gables, Florida, United States

Key Dates

Start Date

August 1, 2015

Primary Completion Date

November 1, 2016

Completion Date

August 3, 2017

Last Updated

June 17, 2020

Enrollment

1,257

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

Ixekizumab

DRUG

Placebo

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis