Phase 3
Completed N=363
A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT02349295 ↗Enrolled (actual)
363
Serious AEs
5.1%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20) — 19.5; 53.3; 48.0 Percentage of Participants — p=<0.001
◆ Published Evidence
Emerging
16citations · ~4 / year
Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials.
Summary
The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.
Linked Publications (5)
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Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials.
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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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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 Index (ACR20) |
19.5; 53.3; 48.0 | <0.001 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
-0.2; -0.6; -0.4 | — |
| SECONDARY Percentage of Participants Achieving ACR20 |
22.0; 50.0; 48.0 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50) |
5.1; 35.2; 33.3 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70) |
0; 22.1; 12.2 | — |
| SECONDARY Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 |
10.4; 57.4; 61.8 | — |
| SECONDARY Percentage of Patients Achieving Minimal Disease Activity (MDA) |
3.4; 27.9; 23.6 | — |
| SECONDARY Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI) |
21.7; 35.3; 31.0 | — |
| SECONDARY Change From Baseline in Itch Numeric Rating Scale (NRS) |
-0.7; -3.4; -3.3 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) |
-6.2; -12.7; -12.5 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) |
-5.0; -8.5; -7.4 | — |
| SECONDARY Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS) |
-21.4; -36.9; -33.5 | — |
| SECONDARY Change From Baseline in Patients Global Assessment of Disease Activity VAS |
-19.0; -40.7; -37.3 | — |
| SECONDARY Change From Baseline in Physicians Global Assessment of Disease Activity VAS |
-18.3; -40.0; -37.9 | — |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) |
-3.6; -11.8; -9.8 | — |
| SECONDARY Change From Baseline in Disease Activity Score-CRP (DAS28-CRP) |
-0.8; -2.1; -1.8 | — |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score |
-2.1; -3.7; -3.6 | — |
| SECONDARY Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score |
-0.7; -2.0; -2.1 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS) |
3.3; 8.9; 8.2 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS) |
0.9; 3.6; 4.0 | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) |
1; 8; 4 | — |
| SECONDARY Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab |
2.46; 7.96 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab |
141; 143 | — |
| SECONDARY Percentage of Participants Achieving ACR 20 |
58.9; 67.6; 50.0; 60.9; 42.1; 50.5 | — |
| SECONDARY Percentage of Participants Achieving ACR 50 |
38.3; 45.9; 34.8; 43.5; 29.0; 35.1 | — |
| SECONDARY Percentage of Participants Achieving ACR 70 |
20.6; 28.8; 15.2; 23.9; 22.4; 21.6 | — |
Eligibility Criteria
Inclusion Criteria
- Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
- Presence of active psoriatic skin lesion or a 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
- Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
- Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.
Exclusion Criteria
- Current use of biologic agents for treatment of Ps or PsA
- Inadequate response to greater than 2 biologic DMARDs
- Current use of more than one cDMARDs
- Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
- 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 (NCT02349295) 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.