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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03022045•AbbVie

View on ClinicalTrials.gov

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

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Juntendo Univ Urayasu Hosp

Urayasu Shi, Chiba, Japan

Takagi Dermatological Clinic

Obihiro, Hokkaido, Japan

Mie University Hospital

Tsu, Mie-ken, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Shizuoka General Hospital

Shizuoka, Shizuoka, Japan

Tokyo Medical University Hosp

Shinjuku-ku, Tokyo, Japan

Fukuoka University Hospital

Fukuoka, Japan

The University of Tokyo Hosp

Tokyo, Japan

Key Dates

Start Date

January 26, 2017

Primary Completion Date

September 17, 2017

Completion Date

November 19, 2020

Last Updated

November 18, 2021

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

risankizumab

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments