A Study in Japanese Participants With Moderate-to-Severe Psoriasis

Sponsor
Eli Lilly and Company
Study ID
NCT01624233
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.

Key Dates

Start date
Jun 30, 2012
Status verified
Aug 2019
Primary completion
Sep 30, 2013
Completion
Sep 30, 2017

Study Design

Enrollment
91 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 80 mg ixekizumab
    Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.

Primary Outcome Measure

Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI) [ Time Frame: Week (Wk) 12 ]

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