Study to assess the efficacy, safety and tolerability of secukinumab in Japanese subjects with GPP
Phase 3
- Conditions
- Generalized Pustular Psoriasis (GPP)
- Registration Number
- JPRN-jRCT2080222256
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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 more than or equal to 10%
Exclusion Criteria
*Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.
*At baseline, total score of JDA severity index for GPP more than or equal to 14
*Drug-induced psoriasis
*Ongoing use of prohibited psoriasis treatments.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Propotion of subjects who experience treatment success of secukinumab at Week 16 [Time Frame: Week 16]<br><br>Treatment success is defined as Minimally improved, Much improved or Very much improved in Clinical global impression (CGI)
- Secondary Outcome Measures
Name Time Method Clinically meaningful success of secukinumab at week 16 [Time Frame: Week 16]<br><br>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 comedication together with other immunomodulatory drug: a. ONLY IF the comedication 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.<br>Treatment success and the clinically meaningful success of secukinumab at Week 52 [Time Frame: Week 52]<br><br><br>CGI [Time Frame: every 4 weeks]<br>CGI has five categories: Very much improved, Much improved, Minimally improved, No change and Wesened.