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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Biological: Secukinumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457<br>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<br>* Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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generalized pustular psoriasis, skin condition, skin disease,