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

Phase 4

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Ixekizumab; Drug: Guselkumab; Drug: Placebo

• Registration Number: NCT03573323
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-29
• Study Start: 2018-11-09
• Primary Completion: 2019-07-15
• Study Completion: 2020-01-08
• Status Verified: 2020-02
• Results First Submitted: 2020-07-10
• Results First Submitted QC: 2020-07-10
• Last Update Submitted: 2020-07-10
• Results First Posted: 2020-07-28
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1027

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.
• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guselkumab	Placebo	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Ixekizumab	Ixekizumab	A starting dose of 160 milligram (mg) of ixekizumab was given as 2 subcutaneous (SC) injections at Week 0. During the Induction Period, ixekizumab 80 mg was given every 2 weeks (Q2W) at Weeks 2, 4, 6, 8, 10, and 12. During the Extension Period, ixekizumab 80 mg was given as 1 SC injection (Q4W) every 4 weeks at Weeks 16 and 20. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.
Guselkumab	Guselkumab	During the Induction Period, guselkumab 100 mg was given as 1 SC injection at Weeks 0, 4 and 12. 1 placebo injection (to maintain the blind) was given at Weeks 0, 2, 6, 8, and 10. During the Extension Period, guselkumab 100 mg was given at Week 20. 1 placebo injection (to maintain the blind) was given at Week 16. The Post Treatment Follow Up Period was for safety monitoring following the last treatment period.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100)	Week 12	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving PASI 100	Week 24	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Percentage of Participants Achieving PASI 75	Week 2	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Percentage of Participants Achieving PASI 90	Week 8	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0)	Week 12	The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.
Percentage of Participants Achieving PASI 50	Week 1	The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 50 were defined as having an improvement of at least 50% in the PASI scores compared to baseline.

Trial Locations

Locations (120)

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

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