Overview

This trial is active, not recruiting.

Condition psoriasis, arthritic
Treatments ixekizumab, placebo, adalimumab
Phase phase 3
Target TNF-alpha
Sponsor Eli Lilly and Company
Start date December 2012
End date December 2014
Trial size 412 participants
Trial identifier NCT01695239, 13731, I1F-MC-RHAP

Summary

This study will assess the safety and efficacy of ixekizumab (LY2439821) 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 safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Administered by 80 milligram (mg) subcutaneous (SC) injection
ixekizumab LY2439821
Administered SC
(Experimental)
Administered by 80 mg SC injection
ixekizumab LY2439821
Administered SC
(Placebo Comparator)
Placebo for ixekizumab and placebo for adalimumab administered by SC injection
placebo
Administered SC
(Active Comparator)
Administered by 40 mg SC injection
adalimumab
Administered SC

Primary Outcomes

Measure
Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: American College of Rheumatology 20 Index (ACR20)
time frame: 24 Weeks

Secondary Outcomes

Measure
Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: modified Total Sharp Score (mTSS)
time frame: Baseline through 24 Weeks
Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: ACR20
time frame: Baseline through 24 Weeks
Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: Non-Arthritic Disease Assessments
time frame: Baseline through 24 Weeks
Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO)
time frame: Baseline through 24 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

Official title A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.