Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Novartis Pharmaceuticals132 enrolled

Overview

The study is designed to explore the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkers.

All subjects will undergo a 16 week run-in phase (open label). At Week 16, an evaluation of the PASI response will be performed. Patients who achieve a PASI reduction of less than 98 percent will complete the study at Week 16 and be referred to routine clinical care for psoriasis by the investigator. Patients who achieve extensive remission (PASI reduction by 98-100 percent) at Week 16 will enter the randomized withdrawal phase (blinded) where they will be randomized to receive either secukinumab or matching placebo and will complete the study at Week 32.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

132

Conditions

Psoriasis

Interventions

SecukinumabBIOLOGICAL

150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)

PlaceboBIOLOGICAL

Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Chronic moderate to severe plaque type psoriasis as diagnosed by a qualified physician at least 6 months prior to baseline and with a PASI score \> 10 at baseline. * Psoriasis patients with pruritus intensity of ≥ 30 on a 100-point VAS, with a recall period of 24h as part of the PGA-CP, both, at screening and at baseline. Key Exclusion Criteria: * Underlying conditions other than psoriasis which in the opinion of the investigator currently cause or influence pruritus of the skin (e.g. drug induced pruritus, renal insufficiency, diabetes). * Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and guttate) at screening or study start. * Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to. If the use of any of the prohibited treatments is required, then the subject may not be included into the study. * Pregnancy, breast feeding or inadequate contraception (if necessary)

Locations (19)

Novartis Investigative Site

Bad Bentheim, Germany

Novartis Investigative Site

Berlin, Germany

Outcomes

Primary Outcomes

Pruritus Intensity Visual Analogue Scale Score at Week 32

On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.

Time frame: Week 32

Data from ClinicalTrials.gov

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