Phase 3
Completed N=394
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Source: ClinicalTrials.gov NCT02584855 ↗Enrolled (actual)
394
Serious AEs
3.0%
Results posted
Nov 2019
Primary outcomePrimary: Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA]) — NA; 22.29 Weeks — p=<0.001
◆ Published Evidence
Established
49citations · ~8 / year
Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis.
Summary
The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.
Linked Publications (3)
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Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis.
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Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double-Blind Withdrawal Study.
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Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA]) |
NA; 22.29 | <0.001 sig |
| SECONDARY Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA |
40.5; 86.1 | — |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC) |
64.29; 22.29 | — |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC) |
NA; 28.71 | — |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI) |
NA; 36.00 | <0.001 sig |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA |
NA; NA | <0.001 sig |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score |
NA; 16.14 | <0.001 sig |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score |
NA; 20.57 | <0.001 sig |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI) |
NA; NA | <0.001 sig |
| SECONDARY Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points |
NA; NA | — |
| SECONDARY Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits) |
64.43 | — |
| SECONDARY Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA |
4.71; 4.14 | — |
| SECONDARY Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) |
-0.79; -0.67 | — |
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)
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 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 (NCT02584855) 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.