Phase 3
Completed N=1,224
A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)
Source: ClinicalTrials.gov NCT01597245 ↗Enrolled (actual)
1,224
Serious AEs
5.8%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) — 2.4; 36.0; 72.9; 83.2 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
13citations · ~3 / year
Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
Summary
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.
Linked Publications (5)
-
Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
-
A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
-
Sustained Improvements in Clinical and Patient-Reported Outcomes and Quality of Life Through 5 Years Among Ixekizumab-Treated Patients with Complete Clearance of Scalp Psoriasis by Week 60.
-
Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis.
-
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 Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) |
2.4; 36.0; 72.9; 83.2 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) |
2.4; 41.6; 77.5; 89.7 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA]) |
0.6; 5.9; 32.3; 41.9 | 0.005 sig |
| SECONDARY Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI]) |
0.6; 18.7; 59.7; 70.7 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 100% (PASI100) |
0.6; 5.3; 30.8; 40.5 | 0.008 sig |
| SECONDARY Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60 |
6.3; 40.9; 74.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline |
14.1; 57.8; 76.8; 85.1 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO]) |
-2.0; -7.7; -9.4; -10.4 | <0.001 sig |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) |
-0.82; -5.34; -7.39; -8.60 | 0.002 sig |
| SECONDARY Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score |
-3.8; -14.8; -18.5; -18.7 | <0.001 sig |
| SECONDARY Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis |
0.5; -12.4; -20.3; -20.6 | <0.001 sig |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score |
0.1; -0.3; -0.7; -0.9 | 0.150 |
| SECONDARY Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) |
-1.5; -3.7; -3.2; -3.9; -0.4; -16.6 | 0.026 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores |
-0.4495; 2.5498; 4.5726; 3.7964; -0.0955; 2.3221 | <0.001 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity |
-0.4; -2.1; -3.0; -3.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement |
43.6; 71.6; 85.3; 88.5; 30.9; 61.1 | <0.001 sig |
| SECONDARY Percentage of Participants With Anti-Ixekizumab Antibodies |
0; 2.9; 14.1; 10.4 | — |
Eligibility Criteria
Inclusion Criteria
- Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug
- At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
- Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug
- Candidate for phototherapy and/or systemic therapy
- Men must agree to use a reliable method of birth control or remain abstinent during the study
- Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion Criteria
- Pustular, erythrodermic, and/or guttate forms of psoriasis
- History of drug-induced psoriasis
- Prior use of etanercept
- Clinically significant flare of psoriasis during the 12 weeks prior to randomization
- Concurrent or recent use of any biologic agent
- Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
- Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- Serious disorder or illness other than plaque psoriasis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT01597245) 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.