A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Phase 1

• Conditions: Arthritic Psoriasis; MedDRA version: 15.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-002326-49-GB
• Lead Sponsor: Eli Lilly & Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-26
• Study Completion: 2017-09-22
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 416

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

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 392
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 3 months prior to randomization
•Breastfeeding or nursing (lactating) women

Study & Design

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