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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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222087
Enrollment
Unknown
Registered
2013-05-22
Start date
2013-05-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis, Arthritic

Interventions

investigational material(s) Generic name etc : ixekizumab (LY2439821) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration f

Sponsors

Quintiles Transnational Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026