Clinical trial NCT01952015: Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: generalized pustular psoriasis
skin condition
skin disease,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-09-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
timeFrame: 52 weeks
measure: Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
timeFrame: week 148
measure: Summary of Clinical Global Impression up to End of Trial
timeFrame: up to week 148 (End of Trial)
measure: Summary of JDA Total Score Category for GPP by Visit up to End of Trial
timeFrame: up to week 148 (End of Trial)
measure: The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
timeFrame: up to week 148 (end of trial)
measure: Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
timeFrame: up to week 148 (end of trial)
measure: Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
timeFrame: Up to week 148 (end of treatment)
measure: Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
timeFrame: up to week 52
Other outcomes:
Locations:
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Asahikawa-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Inashiki-gun
country: Japan
facility: Novartis Investigative Site
state: Ibaraki
city: Shimotsuke city
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Kofu-city
country: Japan
facility: Novartis Investigative Site
state: Yamanashi
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: