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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 )

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.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: Secukinumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 21, 2013
Actual Primary Completion Date : March 15, 2016
Actual Study Completion Date : March 15, 2016


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).




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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".


  2. 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".

  3. 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".


  4. 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.

  5. 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.


  6. 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.


  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952015


Locations
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Japan
Novartis Investigative Site
Fukuoka city, Fukuoka, Japan, 814 0180
Novartis Investigative Site
Kitakyushu-city, Fukuoka, Japan, 800-0296
Novartis Investigative Site
Asahikawa-city, Hokkaido, Japan, 078-8510
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-0063
Novartis Investigative Site
Inashiki-gun, Ibaraki, Japan, 300-0395
Novartis Investigative Site
Shimotsuke city, Tochigi, Japan, 329-0498
Novartis Investigative Site
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
Kofu-city, Yamanashi, Japan, 400-8506
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01952015    
Other Study ID Numbers: CAIN457A1302
First Posted: September 27, 2013    Key Record Dates
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
generalized pustular psoriasis
skin condition
skin disease,
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs