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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 November 2021 |
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Main ID: |
NCT03022045 |
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Date of registration:
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13/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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January 26, 2017 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03022045 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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AbbVie Inc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: risankizumab
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Primary Outcome(s)
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Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16
[Time Frame: Week 16]
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Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16
[Time Frame: Week 16]
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Secondary Outcome(s)
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Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16
[Time Frame: Week 16]
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Percentage of Participants With EP Achieving PASI90 at Week 16
[Time Frame: Week 16]
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Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52
[Time Frame: Week 52]
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Percentage of Participants With EP Achieving EP Clinical Response at Week 52
[Time Frame: Week 52]
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Percentage of Participants With GPP Achieving PASI90 at Week 52
[Time Frame: Week 52]
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Percentage of Participants With EP Achieving PASI90 at Week 52
[Time Frame: Week 52]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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