Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

Phase 3CompletedNCT02008890

Novartis Pharmaceuticals237 enrolled

Overview

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

237

Conditions

Palmoplantar Pustular Psoriasis

Interventions

Secukinumab 300mgBIOLOGICAL

Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered

Secukinumab 150mgBIOLOGICAL

secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered

PlaceboBIOLOGICAL

secukinumab placebo s.c. (two PFS injections of placebo) self-administered

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Palmoplantar pustular psoriasis for at least 6 months before Randomization * Moderate to severe palmoplantar pustular psoriasis as defined at Baseline by: * ppPASI score of ≥ 12 and * DLQI ≥ 10 * Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by: * Topical treatment, and/or * Phototherapy, and/or * Previous systemic therapy Exclusion Criteria: * Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis) * Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis * Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study * Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to * Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab) * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment * Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy * Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer Other protocol-defined inclusion/exclusion criteria may apply.

Locations (68)

Outcomes

Primary Outcomes

Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)

The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.

Time frame: Baseline to Week 16

Secondary Outcomes

ppPASI: Absolute Change From Baseline to Week 16

A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.

Time frame: Baseline to Week 16

Percentage of Participants With ppPASI 75 Response Over Time (Period 1)

A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.

Data from ClinicalTrials.gov

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Novartis Investigative Site

Feldkirch, Austria

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Liège, Belgium

Novartis Investigative Site

Limoges, Haute Vienne, France

...and 58 more locations