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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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12 December 2020 |
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Main ID: |
NCT01952015 |
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Date of registration:
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24/09/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
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Scientific title:
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A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability in Japanese Subjects With Generalized Pustular Psoriasis |
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Date of first enrolment:
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August 21, 2013 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01952015 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group 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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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At baseline, presence of GPP classified on the basis of the criteria for diagnosis of
GPP by Japanese Dermatological Association (JDA)
- At baseline, erythema area with pustule = 10%
Exclusion Criteria:
- Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.
- At baseline, : total score of JDA severity index for GPP = 14
- Drug-induced psoriasis
- Ongoing use of prohibited psoriasis treatments.
Age minimum:
18 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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Biological: Secukinumab
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Primary Outcome(s)
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Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
[Time Frame: up to week 148 (end of trial)]
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Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
[Time Frame: up to week 52]
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Summary of JDA Total Score Category for GPP by Visit up to End of Trial
[Time Frame: up to week 148 (End of Trial)]
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The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
[Time Frame: up to week 148 (end of trial)]
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Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
[Time Frame: 52 weeks]
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Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
[Time Frame: Up to week 148 (end of treatment)]
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Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
[Time Frame: week 148]
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Summary of Clinical Global Impression up to End of Trial
[Time Frame: up to week 148 (End of Trial)]
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Secondary ID(s)
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CAIN457A1302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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