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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03022045
Recruitment Status : Active, not recruiting
First Posted : January 16, 2017
Results First Posted : February 6, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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).

Condition or disease Intervention/treatment Phase
Psoriasis Drug: risankizumab Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 26, 2017
Actual Primary Completion Date : September 17, 2017
Estimated Study Completion Date : November 19, 2020


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 Name: 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 Name: ABBV-066 BI 655066




Primary Outcome Measures :
  1. Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16 [ Time Frame: 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.

  2. Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52 [ Time Frame: 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.

  2. Percentage of Participants With EP Achieving EP Clinical Response at Week 52 [ Time Frame: 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).

  3. Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 [ Time Frame: 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.

  4. Percentage of Participants With EP Achieving PASI90 at Week 16 [ Time Frame: 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.

  5. Percentage of Participants With GPP Achieving PASI90 at Week 52 [ Time Frame: 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.

  6. Percentage of Participants With EP Achieving PASI90 at Week 52 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022045


Locations
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Japan
Nagoya City University Hospital
Nagoya-shi, Aichi, Japan, 467-8602
Juntendo Univ Urayasu Hosp
Urayasu Shi, Chiba, Japan, 279-0021
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan, 080-0013
Mie University Hospital
Tsu-shi, Mie, Japan, 514-8507
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan, 573-1191
Shizuoka General Hospital
静岡市, Shizuoka, Japan, 〒420-8527
Tokyo Medical University Hosp
Shinjuku-ku, Tokyo, Japan, 160-0023
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
The University of Tokyo Hosp
Tokyo, Japan, 113-0033
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Statistical Analysis Plan  [PDF] January 5, 2018
Study Protocol  [PDF] January 23, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03022045    
Other Study ID Numbers: M15-988
First Posted: January 16, 2017    Key Record Dates
Results First Posted: February 6, 2019
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AbbVie:
Generalized Pustular Psoriasis
Erythrodermic Psoriasis
risankizumab
Japanese
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs