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
NCT ID: NCT03022045
Last Updated: 2021-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
18 participants
INTERVENTIONAL
2017-01-26
2020-11-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Risankizumab 75 mg
Participants randomized to receive risankizumab 75 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
risankizumab
risankizumab administered by subcutaneous injection
Risankizumab 150 mg
Participants randomized to receive risankizumab 150 mg at Week 0, Week 4, and every 12 weeks up to Week 172.
risankizumab
risankizumab administered by subcutaneous injection
Interventions
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risankizumab
risankizumab administered by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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clinical study report synopsis
Other Identifiers
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M15-988
Identifier Type: -
Identifier Source: org_study_id