A Study of Ixekizumab Versus Adalimumab in Participants With Psoriatic Arthritis

INTERVENTION:

Trade Name: Taltz Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

IXEKIZUMAB Other descriptive name: LY2439821 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Trade Name: Humira Product Name: Humira Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

ADALIMUMAB CAS Number: 331731‐18‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐

CONDITION:

Psoriatic Arthritis ; MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05]

PRIMARY OUTCOME:

Main Objective: To assess whether ixekizumab; is superior to adalimumab at; Week 24 in the treatment of; patients with active PsA as; measured by American College of Rheumatology 50 (ACR50); and Psoriasis Area and Severity; Index 100 (PASI 100) Primary end point(s): Proportion of Participants Simultaneously Achieving American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 ; Secondary Objective: To assess whether ixekizumab is noninferior to adalimumab at; Week 24 in the treatment of patients with active PsA as; measured by ACR50; ; To assess whether ixekizumab; is superior to adalimumab at; Week 24 in the treatment of; patients with active PsA as; measured by PASI 100; ; To assess the effect of treatment with ixekizumab compared with adalimumab over 52 weeks as measured by various efficacy and quality of life outcomes Timepoint(s) of evaluation of this end point: Week 24

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 plaque psoriasis 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 495 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

SECONDARY OUTCOME:

Secondary end point(s): Proportion of Participants Achieving ACR50 ; ; Proportion of Participants Achieving PASI100 ; ; Change from Baseline in Tender Joint Count (TJC) ; ; Change from Baseline in Swollen Joint Count (SJC) ; ; Change from Baseline in Participant's Assessment of Pain VAS ; ; Change from Baseline in Participant's Global Assessment of Disease Activity ; ; Change from Baseline in Physician's Global Assessment of Disease Activity ; ; Change from Baseline in C‐Reactive Protein (CRP) ; ; Change from Baseline in Health Assessment Questionnaire‐Disability Index (HAQ‐DI) ; ; Proportion of Participants Simultaneously Achieving ACR50 and PASI100 ; ; Change from Baseline in Disease Activity Score‐CRP (DAS28‐CRP) ; ; Proportion of Participants Achieving Minimal Disease Activity (MDA) ; ; Proportion of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) ; ; Change from Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified) ; ; Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants with Enthesitis at Baseline ; ; Change from Baseline in the Leeds Enthesitis Index (LEI) in Participants with Enthesitis at Baseline ; ; Change from Baseline in the Leeds Dactylitis Index‐Basic (LDI‐B) in Participants with Dactylitis at Baseline ; ; Change from Baseline in Psoriasis Body Surface Area (BSA) ; ; Change from Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants with Fingernail Involvement at Baseline ; ; Change from Baseline in the Itch NRS; ; Change from Baseline in Fatigue Severity NRS (Fatigue NRS) Score ; ; Change From Baseline in Medical Outcomes Study 36‐item Short Form Health Survey (SF‐36): Physical Component Summary (PCS) and Mental Component Summary (MCS) ; ; Change from Baseline in Measures of Health Utility (EuroQol‐5 Dimensions 5 Level [EQ‐5D 5L]) ; ; Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score; ; Change from Baseline on the Treatment Satisfaction Questionnaire ; ; Change from Baseline in Columbia Suicide Severity Rating Scale (C‐SSRS) Timepoint(s) of evaluation of this end point: Week 24 and 52