NCT01952015CompletedPhase 3
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
Novartis Pharmaceuticals11 sites in 1 country12 target enrollmentStarted: August 21, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 12
- Locations
- 11
- Primary Endpoint
- Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Study Overview
Brief Summary
The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Time Frame: 16 weeks
Treatment success was defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI). Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder.
Secondary Outcomes
- Summary of JDA Total Score Category for GPP by Visit up to End of Trial(up to week 148 (End of Trial))
- Summary of Clinical Global Impression up to End of Trial(up to week 148 (End of Trial))
- Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)(52 weeks)
- Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)(week 148)
- The Japanese Dermatological Association (JDA) Component Score for GPP Over Time(up to week 148 (end of trial))
- Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP(up to week 148 (end of trial))
- Number of Patients With GPP-related Systemic and Topical Co-medication Over Time(up to week 52)
- Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time(Up to week 148 (end of treatment))
Investigators
Study Sites (11)
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