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

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Biological: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01952015

CAIN457A1302

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

AIN457

Experimental group

Description:

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.

Treatment:

Biological: Secukinumab