Overview

This trial is active, not recruiting.

Condition psoriatic arthritis
Treatments ixekizumab, placebo
Phase phase 3
Sponsor Eli Lilly and Company
Start date December 2014
End date September 2016
Trial size 360 participants
Trial identifier NCT02349295, 14310, 2011-002328-42, I1F-MC-RHBE

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.

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, 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 administered by SC injection.
placebo
Administered SC

Primary Outcomes

Measure
Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
time frame: Week 24

Secondary Outcomes

Measure
Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores
time frame: Baseline, Week 24
Proportion of Participants with Psoriasis Area and Severity Index (PASI) 75
time frame: Week 12
Percentage of Participants Achieving ACR20
time frame: Week 12 and Week 52 and up to 3 Years
Percentage of Participants Achieving ACR 50/70
time frame: Week 24 and Week 52 and up to 3 Years
Change from Baseline in Leeds Enthesitis Index (LEI)
time frame: Baseline, Week 12
Change from Baseline in Itch Numeric Rating Scale (NRS)
time frame: Baseline, Week 12
Change from Baseline in Tender Joint Count (TJC)
time frame: Baseline, Week 24
Change from Baseline in Swollen Joint Count (SJC)
time frame: Baseline, Week 24
Change from Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)
time frame: Baseline, Week 24
Change from Baseline in Participants Global Assessment of Disease Activity VAS
time frame: Baseline, Week 24
Change from Baseline in Physicians Global Assessment of Disease Activity VAS
time frame: Baseline, Week 24
Change from Baseline in C-Reactive Protein (CRP)
time frame: Baseline, Week 24
Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)
time frame: Baseline, Week 24
Change from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
time frame: Baseline, Week 24
Change from Baseline in Fatigue Severity NRS Score
time frame: Baseline, Week 24
Change from Baseline in 36-Item Short-Form Health Survey (SF-36) Scores
time frame: Baseline, Week 24
Number of Participants with Anti-Ixekizumab Antibodies
time frame: Week 24
Pharmacokinetics (PK): Steady State Concentration of Ixekizumab
time frame: Week 24

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 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

Additional Information

Official title A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.