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

Completed · Phase 4 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT03573323

Run by

Eli Lilly and Company

People needed

1027

Starts

2018-11-09

Expected to finish

2020-01-08

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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• Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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.
• Have had any major surgery within 8 weeks of baseline.
• Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
• Are women who are pregnant, or who are lactating (breast-feeding).

Where it is running

• 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
• Advanced Research Center — Los Alamitos, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Dermatology Clinical Trials — Newport Beach, California, United States
• Quest Dermatology Research — Northridge, California, United States
• Northern California Research Corporation — Sacramento, California, United States
• Advanced Research Center — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• Synergy Dermatology — San Francisco, California, United States
• Southern California Dermatology — Santa Ana, California, United States
• Mosaic Dermatology — Santa Monica, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Unison Clinical Trials — Sherman Oaks, California, United States
• Care Access Research-Walnut Creek — Walnut Creek, California, United States
• Dermatology Physicians of Connecticut — Shelton, Connecticut, United States
• Total Skin and Beauty Dermatology Center PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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