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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Secukinumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring generalized pustular psoriasis, skin condition, skin disease,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AIN457

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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".
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".
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.
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.
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.
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.
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.

Full Information

First Posted
September 24, 2013
Last Updated
March 14, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01952015
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 21, 2013 (Actual)
Primary Completion Date
March 15, 2016 (Actual)
Study Completion Date
March 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
generalized pustular psoriasis, skin condition, skin disease,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIN457
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Intervention Description
Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).
Primary Outcome Measure Information:
Title
Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)
Description
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".
Time Frame
52 weeks
Title
Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)
Description
Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".
Time Frame
week 148
Title
Summary of Clinical Global Impression up to End of Trial
Description
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".
Time Frame
up to week 148 (End of Trial)
Title
Summary of JDA Total Score Category for GPP by Visit up to End of Trial
Description
Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.
Time Frame
up to week 148 (End of Trial)
Title
The Japanese Dermatological Association (JDA) Component Score for GPP Over Time
Description
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.
Time Frame
up to week 148 (end of trial)
Title
Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP
Description
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.
Time Frame
up to week 148 (end of trial)
Title
Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time
Description
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.
Time Frame
Up to week 148 (end of treatment)
Title
Number of Patients With GPP-related Systemic and Topical Co-medication Over Time
Description
Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.
Time Frame
up to week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Fukuoka city
State/Province
Fukuoka
ZIP/Postal Code
814 0180
Country
Japan
Facility Name
Novartis Investigative Site
City
Kitakyushu-city
State/Province
Fukuoka
ZIP/Postal Code
800-0296
Country
Japan
Facility Name
Novartis Investigative Site
City
Asahikawa-city
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Novartis Investigative Site
City
Inashiki-gun
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Facility Name
Novartis Investigative Site
City
Shimotsuke city
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Novartis Investigative Site
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
102-8798
Country
Japan
Facility Name
Novartis Investigative Site
City
Hachioji-city
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Novartis Investigative Site
City
Kofu-city
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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