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

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: risankizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Tokyo, Japan, 113-0033
    • The University of Tokyo Hosp
  • Aichi
    • Nagoya-shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital
  • Chiba
    • Urayasu Shi, Chiba, Japan, 279-0021
      • Juntendo Univ Urayasu Hosp
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital
  • Shizuoka
    • 静岡市, Shizuoka, Japan, 〒420-8527
      • Shizuoka General Hospital
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hosp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Risankizumab 75 mg; Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	Drug: risankizumab; risankizumab administered by subcutaneous injection; Other Names: ABBV-066 BI 655066
EXPERIMENTAL: Risankizumab 150 mg; Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.	Drug: risankizumab; risankizumab administered by subcutaneous injection; Other Names: ABBV-066 BI 655066

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16	GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count [WBC], serum C-reactive protein [CRP], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data.	Week 16
Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16	EP Clinical Response, defined as at least "Minimally Improved" in Clinical Global Impression-Global Improvement (CGI-GI) for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). NRI was used for missing data.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52	GPP Clinical Response defined as at least "Slightly Improved" in the overall improvement rating from baseline according to JDA total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, WBC, serum CRP, and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria.	Week 52
Percentage of Participants With EP Achieving EP Clinical Response at Week 52	EP Clinical Response, defined as at least "Minimally Improved" in CGI-GI for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse).	Week 52
Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.	Week 16
Percentage of Participants With EP Achieving PASI90 at Week 16	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.	Week 16
Percentage of Participants With GPP Achieving PASI90 at Week 52	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.	Week 52
Percentage of Participants With EP Achieving PASI90 at Week 52	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.	Week 52

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• 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.

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2017
• Primary Completion (ACTUAL): September 17, 2017
• Study Completion (ACTUAL): November 19, 2020

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (ESTIMATE): January 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Japanese; risankizumab; Generalized Pustular Psoriasis; Erythrodermic Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: M15-988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No