Phase 3
Completed N=1,346
A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)
Source: ClinicalTrials.gov NCT01646177 ↗Enrolled (actual)
1,346
Serious AEs
8.1%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) — 13; 159; 291; 310 Participants — p=<0.001
◆ Published Evidence
Established
68citations · ~14 / year
Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled trial.
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)
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Long-term efficacy and safety of ixekizumab: A 5-year analysis of the UNCOVER-3 randomized controlled 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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A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis.
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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.
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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 Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) |
13; 159; 291; 310 | <0.001 sig |
| PRIMARY Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) |
14; 204; 325; 336 | <0.001 sig |
| SECONDARY Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) |
0; 33; 139; 155 | <0.001 sig |
| SECONDARY Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) |
6; 98; 252; 262 | <0.001 sig |
| SECONDARY Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) |
0; 28; 135; 145 | <0.001 sig |
| SECONDARY Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] |
33; 200; 250; 264 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score |
-1.7; -8.0; -9.6; -10.2 | <0.001 sig |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score |
1.6362; -6.4015; -9.9793; -10.4145 | <0.001 sig |
| SECONDARY Percent of Body Surface Area (BSA) Involvement of Psoriasis |
-0.7; -16.4; -23.2; -23.2 | <0.001 sig |
| SECONDARY Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score |
-5.0; -15.9; -18.2; -18.8 | <0.001 sig |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)] |
-0.3; -0.5; -0.9; -1.3 | 0.473 |
| SECONDARY Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) |
0.0; -2.8; -2.0; -2.5; -2.5; -21.1 | 0.006 sig |
| SECONDARY Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores |
-0.1993; 3.1176; 4.1143; 3.9620; 1.1305; 2.6486 | <0.001 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Severity |
-0.5; -2.3; -3.1; -3.1 | <0.001 sig |
| SECONDARY Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement |
26; 77; 75; 78 | <0.001 sig |
| SECONDARY Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement |
19; 63; 69; 72 | <0.001 sig |
| SECONDARY Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement |
15; 57; 54; 61 | <0.001 sig |
| SECONDARY Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies |
2; 8; 52; 23 | — |
Eligibility Criteria
Inclusion Criteria
- Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization
- At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
- 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 randomization
- 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 (NCT01646177) 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.