A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis

Sponsor
Eli Lilly and Company
Study ID
NCT02561806
Phase
PHASE3
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 efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

Key Dates

Start date
Oct 31, 2015
Status verified
Jun 2020
Primary completion
May 31, 2016
Completion
Oct 31, 2017

Study Design

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

Arms

  • Active Comparator: Ustekinumab
    45 mg ustekinumab given as SC injection for participants ≤100 kilograms (kg) and 90 mg SC injection for participants \>100 kg at Week 0, 4, 16, 28, and 40. Placebo for ixekizumab injections will be used for blinding.
  • Experimental: Ixekizumab
    160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg ixekizumab given as a single SC injection once every 2 weeks from week 2 through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 52.Placebo for ustekinumab injections will be used for blinding.

Primary Outcome Measure

Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline [ Time Frame: Week 12 ]

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