Clinical trial NCT02362789: Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers
Official title: Exploratory Study on the Kinetics of Psoriasis Symptoms, Pruritus Intensity and Lesional Biomarkers in Patients With Moderate to Severe Plaque-type Psoriasis Treated With Subcutaneous Secukinumab (300 mg) During a 16 Week Open-label run-in Phase Followed by a 16 Week Randomized, Double-blind, Placebo-controlled Withdrawal Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-02-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pruritus Intensity Visual Analogue Scale Score at Week 32
timeFrame: Week 32
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Bentheim
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dippoldiswalde-Schmiedeberg
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Osnabrueck
country: Germany
facility: Novartis Investigative Site
city: Selters
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Muenster
name: Study Lead
role: PRINCIPAL_INVESTIGATOR
References: