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

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

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 Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Secukinumab

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Fukuoka city, Fukuoka, Japan, 814 0180
      • Novartis Investigative Site
    • Kitakyushu-city, Fukuoka, Japan, 800-0296
      • Novartis Investigative Site
  • Hokkaido
    • Asahikawa-city, Hokkaido, Japan, 078-8510
      • Novartis Investigative Site
    • Sapporo, Hokkaido, Japan, 060-0063
      • Novartis Investigative Site
  • Ibaraki
    • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Novartis Investigative Site
  • Tochigi
    • Shimotsuke city, Tochigi, Japan, 329-0498
      • Novartis Investigative Site
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 102-8798
      • Novartis Investigative Site
    • Hachioji-city, Tokyo, Japan, 192-0032
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Novartis Investigative Site
  • Yamanashi
    • Kofu-city, Yamanashi, Japan, 400-8506
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AIN457; All subjects were assigned to receive 150 mg secukinumab (AIN457) by subcutaneous injections. AIN457 was administered at baseline, weeks 1, 2, 3, 4. Prior to receiving the week 8 dose, all subjects were assigned to the following treatment group based on clinical components of their Clinical Global Impression (CGI) evaluation at week 8.; "No up-titration" group received 1 injection of 150 mg AIN457 at weeks 8, 12, and each visit from week 16 until week 48.; "Up-titration" group received 2 injections of 150 mg AIN457 at weeks 8, 9, 12 and each visit from week 16 until week 48. Subjects who received 150 mg AIN457 can be up-titrated to 300 mg AIN 457 at any visit starting at week 16 based on clinical components of their CGI evaluation and investigator's discretion.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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)
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)
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)
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)
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2013
• Primary Completion (Actual): March 15, 2016
• Study Completion (Actual): March 15, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 27, 2013

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: skin condition; generalized pustular psoriasis; skin disease,
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457A1302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No