Clinical trial NCT03942042: A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Official title: A Multicenter, Open-Label, Post Marketing Clinical Trial to Evaluate the Efficacy And Safety Of Ixekizumab in Patients With Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Pustular Psoriasis
Erythrodermic Psoriasis
Keywords: Generalized Pustular Psoriasis (GPP)
Erythrodermic Psoriasis (EP)
Japan
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Present with GPP or EP based on an investigator-confirmed diagnosis and meet the associated criteria

  * GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status.
  * EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline.
* Candidates for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control during the study
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* History of drug-induced psoriasis
* Concurrent or recent use of any biologic agent
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Have previously received ixekizumab
* Serious disorder or illness other than psoriasis
* Serious infection within the last 12 weeks
* Breastfeeding or nursing (lactating) women

Primary outcomes:
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
timeFrame: Week 12 through Week 20
Secondary outcomes:
measure: Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved
timeFrame: Week 20
measure: Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved
timeFrame: Week 20
measure: Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged
timeFrame: Week 20
measure: Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened
timeFrame: Week 20
measure: Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1)
timeFrame: Week 20
measure: Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75)
timeFrame: Week 20
measure: Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline
timeFrame: Baseline, Week 20
measure: Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis
timeFrame: Baseline, Week 20
measure: Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline, Week 20
measure: Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA)
timeFrame: Week 20
measure: Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb)
timeFrame: Week 20
measure: Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index
timeFrame: Baseline, Week 20
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: Jikei University School of Medicine
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Osaka City University Medical School Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Morita A, Okubo Y, Morisaki Y, Torisu-Itakura H, Umezawa Y. Ixekizumab 80 mg Every 2 Weeks Treatment Beyond Week 12 for Japanese Patients with Generalized Pustular Psoriasis and Erythrodermic Psoriasis. Dermatol Ther (Heidelb). 2022 Feb;12(2):481-494. doi: 10.1007/s13555-021-00666-x. Epub 2021 Dec 29.