A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
Purpose
The purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.
Condition
- Plaque Psoriasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have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
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Experimental 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. |
|
More Details
- Status
- Completed
- Sponsor
- Eli Lilly and Company