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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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ClinicalTrials.gov Identifier: NCT01952015
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE September 24, 2013
First Posted Date  ICMJE September 27, 2013
Results First Submitted Date  ICMJE March 15, 2017
Results First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE August 21, 2013
Actual Primary Completion Date March 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
Propotion of subjects who experience treatment success of secukinumab at Week 16 [ Time Frame: 16 weeks ]
Treatment success is defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set) [ Time Frame: 52 weeks ]
    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) [ Time Frame: week 148 ]
    Clinical global impression (CGI) evaluated as "very much improved", "much improved", "Minimally improved".
  • Summary of Clinical Global Impression up to End of Trial [ Time Frame: up to week 148 (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 [ Time Frame: up to week 148 (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 [ Time Frame: up to week 148 (end of trial) ]
    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 [ Time Frame: up to week 148 (end of trial) ]
    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 [ Time Frame: Up to week 148 (end of treatment) ]
    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 [ Time Frame: up to week 52 ]
    Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
  • Clinically meaningful success of secukinumab at week 16 [ Time Frame: 16 weeks ]
    Clinically meaningful success is defined as follows: 1) For subjects who receive secukinumab as monotherapy: "Minimally improved", "Much improved" or "Very much improved" in CGI, 2) For subjects who receive secukimumab as co-medication together with other immunomodulatory drug: a. ONLY IF the co-medication is not meaningfully reduced: "Minimally improved", "Much improved" or "Very much improved" in CGI, b. ONLY IF the co-medication is meaningfully reduced: "No-change", "Minimally improved", "Much improved" or "Very much improved" in CGI.
  • Treatment success and the clinically meaningful success of secukinumab at Week 52 [ Time Frame: 52 weeks ]
  • CGI [ Time Frame: evert 4 weeks ]
    CGI has five categories: Very much improved, Much improved, Minimally improved, No change and Wesened.
  • Change from baseline in the total score and the category of the JDA severity index for GPP [ Time Frame: every 4 weeks ]
    JDA severity index for GPP consists of area of etythema with pustules, area of erythema (total), area of edema, fever, WBC, hsCRP and serum albumin. The total score of JDA severity index for GPP is assigned a score of 0-17 (0=best, 17=worst).
  • Change from baseline in components of the JDA severity index for GPP [ Time Frame: every 4 weeks ]
    Area of erythema with pustules, area of erythema (total), area of edema are rated as 0 to 3. Fever, WBC, hsCRP and serum albumin are rated as 0 to 2.
  • Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP [ Time Frame: every 4 weeks ]
  • Clinical safety and tolerability of secukinumab [ Time Frame: Up to 60 weeks ]
    Clinical safety and tolerability of secukinumab as assessed by vital signs, clinical laboratory variables, ECGs, and adverse events monitoring.
  • Change from baseline in SF-36 [ Time Frame: every 4 weeks ]
    The Short Form Health Survey (SF-36) ) is a widely used and extensively studied instrument to measure health-related quality of life among healthy subjects and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health.
  • Change from baseline in DLQI [ Time Frame: every 4 weeks ]
    The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts.
  • Use of systemic co-medication to treat GPP [ Time Frame: every 4 weeks ]
    Use of systemic co-medication to treat GPP, in subjects who have active GPP treatment at baseline.
  • Use of topical co-medication to treat GPP [ Time Frame: every 4 weeks ]
    Use of topical co-medication to treat GPP, in subjects who have active GPP treatment at baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE 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).
Study Arms  ICMJE 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.

Intervention: Biological: Secukinumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2013)
10
Actual Study Completion Date  ICMJE March 15, 2016
Actual Primary Completion Date March 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01952015
Other Study ID Numbers  ICMJE CAIN457A1302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP