Phase 3
Completed N=1,296
A Phase 3 Study in Participants With Moderate to Severe Psoriasis
Source: ClinicalTrials.gov NCT01474512 ↗Enrolled (actual)
1,296
Serious AEs
6.5%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) — 3.2; 76.4; 81.8 percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
835citations · ~84 / year
Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis.
Summary
This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.
Linked Publications (5)
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Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis.
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Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) |
3.2; 76.4; 81.8 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI) |
3.9; 82.6; 89.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) |
0.0; 34.5; 37.0 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI) |
0.5; 64.6; 70.9; 0.0; 33.6; 35.3 | <0.001 sig |
| SECONDARY Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period |
7.5; 37.4; 72.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline |
15.5; 80.5; 85.9 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score |
-1.0; -10.7; -11.1 | <0.001 sig |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) |
2.17; -7.19; -7.24 | <0.001 sig |
| SECONDARY Percent of Body Surface Area (BSA) Involvement of Ps |
1.3; -21.4; -22.4 | <0.001 sig |
| SECONDARY Change From Baseline in Psoriasis Scalp Severity Index (PSSI) |
-1.8; -18.3; -19.2 | <0.001 sig |
| SECONDARY Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO) |
0.2; -3.5; -2.6; 0.8; -24.5; -25.2 | <0.001 sig |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) |
-0.1; -1.0; -1.3 | <0.001 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) |
-0.1747; 4.3081; 4.3159; 0.8729; 3.7386; 4.1293 | <0.001 sig |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) |
-0.2; -3.1; -3.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement |
35.3; 84.0; 82.9; 26.3; 74.8; 77.1 | <0.001 sig |
| SECONDARY Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss) |
7.73; 2.94; NA; NA; NA; NA | — |
| SECONDARY Percentage of Participants With Anti-ixekizumab Antibodies |
0.5; 12.5; 10.3 | — |
Eligibility Criteria
Inclusion Criteria
- Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris 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 during the study
- Women must agree to use 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
- Clinically significant flare of psoriasis during the 12 weeks prior to randomization
- Concurrent or recent use of any biologic agent
- Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy 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 (IL)-17 antagonists, including LY2439821
- 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 (NCT01474512) 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.