A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Phase 1

• Conditions: Arthritic Psoriasis; MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-002328-42-CZ
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-05
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 360

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 psoriatic arthritis 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 342
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

• Current use of biologic agents for treatment of Ps or PsA
• Inadequate response to greater than 2 bDMARDs
• Current use of more than one cDMARD
• Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
• Have received treatment with IL-17 or IL12/23 targeted MAb therapy
• Serious disorder or illness other than psoriatic arthritis
• Serious infection within the last 3 months
• Breastfeeding or nursing (lactating) women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis who are biologic disease-modifying antirheumatic drugs (bDMARD0-experienced, as measured by the percentage of patients achieving ACR20 response at Week 24.;Primary end point(s): American College of Rheumatology 20 Index (ACR20);<br> Secondary Objective: • Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks<br> • Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks<br> • Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks<br> ;Timepoint(s) of evaluation of this end point: At 24 Weeks

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): • ACR20<br> • Non-Arthritic Disease Assessments<br> • Patient Reported Outcomes (PRO)<br> ;Timepoint(s) of evaluation of this end point: Baseline through 24 Weeks