A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

Sponsor
Eli Lilly and Company
Study ID
NCT03151551
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

Key Dates

Start date
Aug 24, 2017
Status verified
Sep 2019
Primary completion
Nov 15, 2018
Completion
Sep 4, 2019

Study Design

Enrollment
566 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ixekizumab
    160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.
  • Active Comparator: Adalimumab
    80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Primary Outcome Measure

Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100) [ Time Frame: Week 24 ]

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