Phase 3
Completed N=417
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
Psoriasis, Arthritic
Source: ClinicalTrials.gov NCT01695239 ↗
Enrolled (actual)
417
Serious AEs
5.3%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) — 30.2; 57.4; 57.9; 62.1 percentage of participants — p=<0.001
◆ Published Evidence
Emerging
8citations · ~3 / year
Ixekizumab Efficacy in Patients with Severe Peripheral Psoriatic Arthritis: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (SPIRIT-P1).
Summary
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.
Linked Publications (5)
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Ixekizumab Efficacy in Patients with Severe Peripheral Psoriatic Arthritis: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (SPIRIT-P1).
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Comparative performance of composite measures from two phase III clinical trials of ixekizumab in psoriatic arthritis.
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Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint.
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Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials.
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Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) |
30.2; 57.4; 57.9; 62.1 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving ACR20 Response |
31.1; 51.5; 57.0; 60.2 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response |
15.1; 38.6; 40.2; 46.6 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score |
5.7; 25.7; 23.4; 34.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) |
-0.1797; -0.3712; -0.4431; -0.4963 | — |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS]) |
0.49; 0.10; 0.17; 0.08 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) |
10.9; 55.2; 71.2; 80.4; 6.3; 37.3 | — |
| SECONDARY Change From Baseline in Leeds Enthesitis Index (LEI) |
-0.8; -0.9; -1.3; -1.4 | — |
| SECONDARY Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) |
0.2; -1.4; -2.6; -2.8 | — |
| SECONDARY Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) |
-1.3; -1.5; -1.6; -1.9 | — |
| SECONDARY Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES) |
0.07; 0.01; 0.04; 0.01; 0.44; 0.12 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) |
2.94; 6.78; 7.45; 8.24; 2.67; 4.22 | — |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO]) |
-0.9; -1.6; -0.8; -0.7 | — |
| SECONDARY Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease |
-0.835; -1.743; -1.955; -2.036 | — |
| SECONDARY Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified) |
32.1; 58.4; 57.9; 66.0 | — |
| SECONDARY Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline |
17.1; 62.2; 65.4; 73.2 | — |
| SECONDARY Percent Change From Baseline in Body Surface Area (BSA) |
-2.7; -9.5; -12.0; -10.6 | — |
| SECONDARY Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline |
-2.4; -10.7; -14.0; -15.5 | — |
| SECONDARY Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B) |
-25.4; -57.1; -57.1; -48.3 | — |
| SECONDARY Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
-1.25; -2.42; -2.74; -2.91 | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb) |
0; 6; 5; 0; 0; 0 | — |
| SECONDARY Percent Change in American College of Rheumatology-N (ACR-N) Score |
-4.182; 28.517; 33.509; 30.391 | — |
| SECONDARY Change From Baseline in Tender Joint Counts (TJC) |
-4.7; -10.1; -11.9; -13.6 | — |
| SECONDARY Change From Baseline in Swollen Joint Counts (SJC) |
-3.5; -6.1; -7.0; -8.3 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain VAS |
-14.0; -30.0; -29.6; -31.6 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS |
-14.8; -31.6; -33.8; -35.6 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity VAS |
-24.2; -34.7; -38.5; -42.0 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) |
-3.873; -7.512; -8.804; -8.942 | — |
| SECONDARY Change From Baseline in Leeds Enthesitis Index (LEI) |
-0.8; -0.9; -1.3; -1.4 | — |
| SECONDARY Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) |
10.9; 55.2; 71.2; 80.4; 6.3; 37.3 | — |
| SECONDARY Change From Baseline in Itching Severity Using the Itch NRS |
-0.3; -1.7; -2.9; -2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
- Presence of active psoriatic skin lesion or a personal history of plaque psoriasis (Ps)
- 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
- Current or prior use of biologic agents for treatment of Ps or PsA
- Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
- Current use of more than one conventional DMARD
- Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- Serious disorder or illness other than psoriatic arthritis
- Serious infection within the last 3 months
- Breastfeeding or nursing (lactating) women
Data sourced from ClinicalTrials.gov (NCT01695239) 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.