Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952015
• Other study ID #: CAIN457A1302
• Status: Completed
• Phase: Phase 3
• Start date: August 21, 2013
• Est. completion date: March 15, 2016

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 15, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Secukinumab
Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Asahikawa-city	Hokkaido
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Inashiki-gun	Ibaraki
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kofu-city	Yamanashi
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Shimotsuke city	Tochigi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)	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.	16 weeks
Secondary	Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)	Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as "very much improved", "much improved", "minimally improved".; Two patients did not achieve treatment success at week 52 with CGI evaluated as "missing" and both were imputed as "no treatment success".	52 weeks
Secondary	Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)	Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".	week 148
Secondary	Summary of Clinical Global Impression up to End of Trial	Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened.; Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as "no treatment success".	up to week 148 (End of Trial)
Secondary	Summary of JDA Total Score Category for GPP by Visit up to End of Trial	Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.	up to week 148 (End of Trial)
Secondary	The Japanese Dermatological Association (JDA) Component Score for GPP Over Time	The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin.; The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2.; The higher the JDA severity index for GPP score the worse the outcome.	up to week 148 (end of trial)
Secondary	Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP	The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/µL), C-reactive protein (mg/L), serum albumin (g/dL).; Percent change=100 x Absolute change/post baseline.	up to week 148 (end of trial)
Secondary	Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time	DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay & Khan 94). The measure is self-admin. & includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute & chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life.	Up to week 148 (end of treatment)
Secondary	Number of Patients With GPP-related Systemic and Topical Co-medication Over Time	Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.	up to week 52