Phase 4
Completed N=1,027
A Study of Ixekizumab (LY2439821) Compared to Guselkumab in Participants With Moderate-to-Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT03573323 ↗Enrolled (actual)
1,027
Serious AEs
2.2%
Results posted
Jul 2020
Primary outcomePrimary: Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) — 41.3; 24.9 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
116citations · ~23 / year
A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial.
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.
Linked Publications (4)
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A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial.
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Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
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Speed and Cumulative Responses According to Body Regions in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Ixekizumab (Interleukin-17A Antagonist) versus Guselkumab (Interleukin-23p19 Inhibitor).
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Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving 100% Improvement From Baseline in Psoriasis Area and Severity Index (PASI 100) |
41.3; 24.9 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 75 |
22.9; 5.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 90 |
58.5; 35.9 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 100 |
50.0; 52.3 | 0.414 |
| SECONDARY Percentage of Participants Achieving PASI 90 |
58.5; 35.9 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) (0) |
41.9; 25.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 50 |
27.5; 9.3 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 100 |
50.0; 52.3 | 0.414 |
| SECONDARY Percentage of Participants Achieving PASI 100 |
50.0; 52.3 | 0.414 |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03573323) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.