Phase 3
Completed N=302
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT02561806 ↗Enrolled (actual)
302
Serious AEs
2.1%
Results posted
Feb 2018
Primary outcomePrimary: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline — 42.2; 72.8 percentage of participants — p=<0.001
◆ Published Evidence
Established
39citations · ~7 / year
Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).
Summary
The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.
Linked Publications (3)
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Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S).
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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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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 With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline |
42.2; 72.8 | <0.001 sig |
| SECONDARY Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline |
68.7; 88.2 | <0.001 sig |
| SECONDARY Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline |
14.5; 36 | 0.009 sig |
| SECONDARY Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline |
57.2; 83.6 | <0.001 sig |
| SECONDARY Percentage of Participants With a sPGA (0) Remission |
18.1; 41.9 | 0.021 sig |
| SECONDARY Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis |
-16.92; -22.55 | — |
| SECONDARY Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score |
-8.34; -10.31 | — |
| SECONDARY Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score |
-16.00; -19.29 | — |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score |
-5.02; -12.24 | — |
| SECONDARY Change From Baseline in Itch Numeric Rating Scale (NRS) |
-4.12; -4.56 | — |
| SECONDARY Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100) |
-29.92; -33.32 | — |
| SECONDARY Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1) |
44.6; 61.0 | 0.012 sig |
| SECONDARY Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale |
-0.96; -1.20 | — |
| SECONDARY Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale. |
-0.90; -1.27 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score; |
3.10; 5.03 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score |
2.36; 2.96 | — |
| SECONDARY Change From Baseline on Patient Global Assessment of Disease Severity (PatGA) |
-2.60; -3.07 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) "Bolt On" Psoriasis (PSO) -Index |
0.11; 0.15 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS |
8.75; 12.24 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score |
0.12; 0.15 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism |
-1.42; -0.46 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism |
-15.53; -16.91 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score. |
-15.05; -16.27 | — |
| SECONDARY Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work |
-19.14; -23.06 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic plaque psoriasis for at least 6 months before baseline
- Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
- Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
- Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment
Exclusion Criteria
- Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
- History of drug-induced psoriasis
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
- Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
- Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent <5 half-lives prior to baseline
- Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab 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, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
- Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
- Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
- Have a known allergy or hypersensitivity to latex
- Have had any major surgery within 8 weeks of baseline or will require such during the study
- Have active or history of malignant disease within 5 years prior to baseline
- Significant uncontrolled disorder
- Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
- Are women who are lactating or breast-feeding
Data sourced from ClinicalTrials.gov (NCT02561806) 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.