Loading clinical trials...

A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A 24-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Guselkumab in Patients With Moderate-to-Severe Plaque Psoriasis

NCT03573323•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
•Are a candidate for phototherapy and/or systemic therapy.
•Have both an Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) score ≥12 at screening and at baseline.
•Have ≥10% body surface area (BSA) involvement at screening and baseline.
•If a male, agree to use a reliable method of birth control during the study.
•If female, agree to use highly effective method of contraception.

Exclusion Criteria

•Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
•Have a history of drug-induced psoriasis.
•Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
•Use of tanning booths for at least 4 weeks before baseline.
•Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept \<28 days; infliximab, adalimumab, certolizumab pegol, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; secukinumab \<5 months; or any other biologic agent (e.g., ustekinumab) \<5 half lives.
•Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
•Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have received treatment with ixekizumab.
•Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
•Have had a live vaccination within 12 weeks of baseline.
•Have a known allergy or hypersensitivity to any biologic therapy.
+3 more criteria

Locations (124)

Total Skin and Beauty Dermatology Center PC

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Alliance Dermatology and Mohs Center

Phoenix, Arizona, United States

Perseverance Research Center

Scottsdale, Arizona, United States

Johnson Dermatology

Fort Smith, Arkansas, United States

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, United States

Wallace Medical Group, Inc.

Beverly Hills, California, United States

California Dermatology and Clinical Research Institute

Encinitas, California, United States

Tien Q. Nguyen, MD inc. DBA First OC Dermatology

Fountain Valley, California, United States

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Key Dates

Start Date

November 9, 2018

Primary Completion Date

July 15, 2019

Completion Date

January 8, 2020

Last Updated

July 28, 2020

Enrollment

1,027

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

Ixekizumab

DRUG

Guselkumab

DRUG

Placebo

DRUG

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

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

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

NCT07250802

Plaque Psoriasis

View study

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: July 28, 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 of Ixekizumab (LY2439821) Compared to Guselkumab 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