FindTrial
Sign In

Study to assess the efficacy, safety and tolerability of secukinumab in Japanese subjects with GPP

A multi-center, open label study of subcutaneous secukinumab in prefilled syringes as mono- or co-therapy to assess the efficacy, safety and tolerability up to 52 weeks in Japanese subjects with generalized pustular psoriasis

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222256
Enrollment
Unknown
Registered
2013-10-18
Start date
2013-10-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Pustular Psoriasis (GPP)

Interventions

investigational material(s) Generic name etc : AIN457 INN of investigational material : Secukinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 more than or equal to 10%

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Propotion of subjects who experience treatment success of secukinumab at Week 16 [Time Frame: Week 16] Treatment success is defined as "Minimally improved", "Much improved" or "Very much improved" in Clinical global impression (CGI)—

Secondary

MeasureTime frame
Clinically meaningful success of secukinumab at week 16 [Time Frame: Week 16] 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. Treatment success and the clinically meaningful success of secukinumab at Week 52 [Time Frame: Week 52] CGI [Time Frame: every 4 weeks] CGI has five categories: Very much improved, Much improved, Minimally improved, No change and Wesened.—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026