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Completed

NCT Number: NCT02362789

Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Bad Bentheim, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Secukinumab

Biological

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

Placebo

Biological

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

Primary outcomes

  1. Pruritus Intensity Visual Analogue Scale Score at Week 32

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: PSORITUS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2015
Registry last updated
Dec 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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