A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Sponsor
Eli Lilly and Company
Study ID
NCT03942042
Phase
PHASE4
Status
Completed

Conditions

  • Erythrodermic Psoriasis
  • Generalized Pustular Psoriasis

Eligibility Criteria

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

Interventions

Study Details

The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.

Key Dates

Start date
Jul 5, 2019
Status verified
Jul 2021
Primary completion
Jul 22, 2020
Completion
Jul 22, 2020

Study Design

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

Arms

  • Experimental: Ixekizumab
    Induction Dosing Period: Participants received 160 milligrams (mg) ixekizumab subcutaneously (SC) as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10. Maintenance Dosing Period: Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study. Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1.

Primary Outcome Measure

Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS [ Time Frame: Week 12 through Week 20 ]

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