Clinical trial NCT03022045: A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Official title: A Phase 3, Randomized, Open-Label Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Generalized Pustular Psoriasis
Erythrodermic Psoriasis
risankizumab
Japanese
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-01-16
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and efficacy of two different dose regimens of risankizumab for Japanese subjects with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Detailed description: Safety and efficacy data through 14 December 2017 are included in the interim analysis, which was conducted after all participants completed the Week 28 visit or discontinued from the study.

Eligibility criteria: Inclusion Criteria:

For GPP

* Have a diagnosis of GPP for at least 60 days prior to informed consent based on the diagnostic criteria of the Japanese Dermatological Association (JDA). Subjects not fulfilling one of the diagnostic criteria i.e., "accompanying systemic symptoms including fever or malaise" at the time of screening can be entered.
* Subjects with an erythema area with pustules accounting for ≥ 10% of the body surface area (BSA), and with a severity assessment criteria score (JDA total score) specified by the JDA of less than 14.
* Must be candidates for systemic therapy or phototherapy for GPP, as assessed by the investigator.

For EP

* Have a diagnosis of EP prior to informed consent.
* Subjects with an inflammatory erythema area accounting for ≥ 80% of the BSA at screening and at the time of the first administration of the study drug.
* Must be candidates for systemic therapy or phototherapy for EP, as assessed by the investigator.

Exclusion Criteria:

* Previous exposure to risankizumab.
* Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted).

For GPP

* Subjects with active ongoing inflammatory diseases other than GPP that might confound trial evaluations according to investigator's judgment.

For EP

* Subjects with active ongoing inflammatory diseases other than EP that might confound trial evaluations according to investigator's judgment.
* Subject diagnosed with medication-induced or medication-exacerbated EP.

Primary outcomes:
measure: Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants With EP Achieving EP Clinical Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16
timeFrame: Week 16
measure: Percentage of Participants With EP Achieving PASI90 at Week 16
timeFrame: Week 16
measure: Percentage of Participants With GPP Achieving PASI90 at Week 52
timeFrame: Week 52
measure: Percentage of Participants With EP Achieving PASI90 at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Urayasu Shi
country: Japan
facility: Juntendo Univ Urayasu Hosp
state: Chiba
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Tsu-shi
country: Japan
facility: Mie University Hospital
state: Mie
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: 静岡市
country: Japan
facility: Shizuoka General Hospital
state: Shizuoka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hosp
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo Hosp
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.