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

NCT01952015 | Completed Phase 3 Results DMC

• 1 other identifier: CAIN457A1302
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Psoriasis

Keywords

generalized pustular psoriasis; skin condition; skin disease,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)

  52 weeks

• Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)

  week 148

• Summary of Clinical Global Impression up to End of Trial

  up to week 148 (End of Trial)

• Summary of JDA Total Score Category for GPP by Visit up to End of Trial

  up to week 148 (End of Trial)

• The Japanese Dermatological Association (JDA) Component Score for GPP Over Time

  up to week 148 (end of trial)

Study Arms (1)

AIN457

EXPERIMENTAL

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

Interventions

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).

AIN457

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Fukuoka, Fukuoka, 814 0180, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 800-0296, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 078-8510, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-0063, Japan

Location

Novartis Investigative Site

Inashiki-gun, Ibaraki, 300-0395, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 102-8798, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0032, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Novartis Investigative Site

Kofu, Yamanashi, 400-8506, Japan

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: August 21, 2013
• Primary Completion: March 15, 2016
• Study Completion: March 15, 2016
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2019-03

Locations

JP (10)