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Completed

NCT Number: NCT01952015

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secukinumab

Biological

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2013
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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