Overview

This trial is active, not recruiting.

Condition psoriatic arthritis
Treatments ixekizumab, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date November 2015
End date March 2017
Trial size 400 participants
Trial identifier NCT02584855, 14518, 2015-002433-22, I1F-MC-RHBF

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Open Label Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36). Double Blind Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104.
ixekizumab LY2439821
Administered SC
(Placebo Comparator)
Open Label Period: Starting dose of 160 mg ixekizumab given as two SC injections at baseline followed by 80 mg given as one SC injection Q2W from week 2 to randomization (week 36). Double Blind Period: Placebo given as one SC injection Q2W any time from randomization to week 104.
ixekizumab LY2439821
Administered SC
placebo
Administered SC
(Experimental)
Open Label Period: Starting dose of 160 mg ixekizumab given as two SC injections at baseline followed by 80 mg given as one SC injection Q2W from week 2 to week 104.
ixekizumab LY2439821
Administered SC

Primary Outcomes

Measure
Time to Relapse [No Longer Meeting Coates Criteria for Minimal Disease Activity (MDA)]
time frame: Double Blind Randomization through Relapse in MDA (Estimated Up To 68 Weeks)

Secondary Outcomes

Measure
Proportion of Participants Who Relapse in MDA
time frame: Double Blind Randomization through Relapse in MDA (Estimated Up To 68 Weeks)
Time to Loss of Response in MDA
time frame: Double Blind Randomization through Loss of Response in MDA (Estimated Up To 68 Weeks)
Time to First Achieving MDA
time frame: Open Label Baseline through First Achieving MDA (Estimated Up To 36 Weeks)
Time to Re-Gain MDA Following Relapse in MDA
time frame: Relapse in MDA After Double Blind Randomization Until Re-Gain MDA (Estimated Up To 64 Weeks)
Change from Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
time frame: Baseline, Week 104

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.