Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

• Register: EUCTR
• Last refreshed on: 31 January 2017
• Main ID: EUCTR2012-005412-25-FI
• Date of registration: 12/04/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Palmoplantar Psoriasis
• Date of first enrolment: 14/05/2013
• Target sample size: 201
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005412-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Finland, Hungary, Israel, Netherlands, Norway, Portugal, Russian Federation, Slovakia, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Medical Information Service
• Affiliation: Novartis Finland Oy

• Name: Medical Information Service
• Affiliation: Novartis Finland Oy

Key inclusion & exclusion criteria

Inclusion criteria:
•Men or women at least 18 years at the time of screening
•Subjects should have chronic moderate to severe plaque type psoriasis for at least 6 months prior to entering the study, including significant involvement of plaque type psoriasis on the palms and soles defined by a palmplantar Investiator Global Assessment (ppIGA) score of > 3 (on a 5-point scale) and at least one extra palmoplantar plaque on the skin
•Subjects should be candidates for systemic therapy, which means having psoriasis considered inadequately controlled by topical treatment (including super potent topical corticosteroid) and/or phototherapy and/or previous systemic therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 191
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
•Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
•Drug-induced psoriasis (e.g. new onset or current exacerbation from ß-blockers, calcium channel inhibitors or lithium)
•Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods have to be adhered to.
•Prior exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or IL-17 Receptor
•Receipt of any investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
•Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
•History of hypersensitivity to constituents of the study treatment. Other protocol-defined inclusion/exclusion criteria may apply



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

moderate to severe palmoplantar psoriasis
MedDRA version: 17.1 Level: LLT Classification code 10037158 Term: Psoriasis palm & soles System Organ Class: 100000004858

Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Intervention(s)

Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: To assess the efficacy of secukinumab 150 mg and 300 mg in subjects
with moderate to severe palmoplantar psoriasis as assessed by the
ppIGA over time up to Week 16 compared to
placebo, and over time up to Week 132
• To assess the efficacy of secukinumab 150 mg and 300 mg in subjects
with moderate to severe palmoplantar psoriasis as assessed by the
ppPASI (palmoplantar Psoriasis Area and
Severity Index) over time up to Week 16 compared to placebo, and over
time up to Week 132
• To investigate the overall safety and tolerability of secukinumab 150
mg and 300 mg

Timepoint(s) of evaluation of this end point: Baseline, 16 weeks

Main Objective: To demonstrate the superiority of secukinumab 150 mg and/or 300 mg
to placebo in subjects with moderate to severe palmoplantar psoriasis as
assessed by the palmoplantar Investigator's Global Assessment (ppIGA)
at Week 16

Primary end point(s): Efficacy:palmoplantar Investigator Global Assessmnet (ppIGA) response after 16 weeks of treatment. Each of the treatment group will be compared to placebo.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Over time up to Week 16 compared to placebo, and over time up to Week 80

2. 16 weeks, 80 weeks

3. Baseline, up to 88 weeks

4. Baseline, 32 weeks, 80 weeks, 88 weeks

Secondary end point(s): 1. Efficacy: palmoplantar Investigator Global Assessment (ppIGA) response

2. Efficacy: palmoplantar Psoriasis Area and Severity Index (ppPASI) over time up to Week 16 compared to placebo, and over time up to Week 80

3. Overall safety and tolerability of secukinumab 150 mg and 300 mg

4. Investigate the development of immunogenicity against secukinumab

Secondary ID(s)

2012-005412-25-ES

CAIN457A2312

Source(s) of Monetary Support

Novartis Pharma Services AG