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: EUCTR2015-002433-22-BG
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] are male or female patients 18 years or older who agree to use reliable method of birth control or remain abstinent during the study
[2] have had diagnosis of active PsA for at least 6 months and meet Classification for Psoriatic Arthritis (CASPAR) criteria
[3] active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
[4] have been treated with 1 or more conventional disease-modifying antirheumatic drugs (DMARDs)
[5] have active psoriatic skin lesions (plaque) or a documented history of plaque psoriasis

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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patients will be excluded from study enrollment if they meet any of the following criteria:
[7] have received any previous treatment or are currently receiving treatment with any biologic or small-molecule therapy for PsA or psoriasis
[10] have had, in the opinion of the investigator, inadequate response to treatment with =4 cDMARDs or immune modifiers
[12] are receiving treatment with more than 1 cDMARD
[20] have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study
[24] have a diagnosis of other inflammatory arthritic syndromes such as RA, ankylosing spondylitis, reactive arthritis, or enteropathic arthritis
[33] have serious disorder other than psoriatic arthritis
[36] had a serious infection within 12 weeks
[43] are positive for human immunodeficiency virus serology
[44] have evidence of or test positive for hepatitis B or hepatitis C virus
[50] are women who are lactating or breastfeeding

Study & Design

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