A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

INTERVENTION:

Product Name: Ixekizumab Product Code: LY2439821 Pharmaceutical Form: Solution for injection in pre‐filled syringe INN or Proposed

INN:

Ixekizumab CAS Number: 1143503‐69‐8 Current Sponsor code: LY2439821 Other descriptive name: Monoclonal Antibody (MAb) Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Adalimumab Product Name: Adalimumab 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‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use

CONDITION:

Arthritic Psoriasis ; MedDRA version: 14.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05]

PRIMARY OUTCOME:

Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 at 24 Weeks Primary end point(s): American College of Rheumatology 20 Index (ACR20) Secondary Objective: · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on modified Total Sharp Score (mTSS) through 24 weeks; · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks; · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Non‐Arthritic Disease Assessments through 24 Weeks; · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks Timepoint(s) of evaluation of this end point: At 24 Weeks

SECONDARY OUTCOME:

Secondary end point(s): · modified Total Sharp Score (mTSS) ; · ACR20 ; · Non‐Arthritic Disease Assessments ; · Patient Reported Outcomes (PRO) ; Timepoint(s) of evaluation of this end point: Baseline through 24 Weeks

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