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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022045
• Other study ID #: M15-988
• Status: Completed
• Phase: Phase 3
• Start date: January 26, 2017
• Est. completion date: November 19, 2020

Study information

• Verified date: November 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 19, 2020
• Est. primary completion date: September 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• risankizumab
risankizumab administered by subcutaneous injection

Locations

Country	Name	City	State
Japan	Shizuoka General Hospital	???	Shizuoka
Japan	Fukuoka University Hospital	Fukuoka
Japan	Kansai Medical University Hospital	Hirakata-shi	Osaka
Japan	Nagoya City University Hospital	Nagoya-shi	Aichi
Japan	Takagi Dermatological Clinic	Obihiro	Hokkaido
Japan	Tokyo Medical University Hosp	Shinjuku-ku	Tokyo
Japan	The University of Tokyo Hosp	Tokyo
Japan	Mie University Hospital	Tsu-shi	Mie
Japan	Juntendo Univ Urayasu Hosp	Urayasu Shi	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis