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NCT Number: NCT02595970

Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.

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Key information

Conditions

Psoriasis Disease Attributes Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Pruritus Recurrence Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Le Mans, Cedex 09, France

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About this study

Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with a history of chronic, moderate to severe plaque psoriasis (PASI ≥12; BSA (body surface area) ≥10 and IGA mod 2011 (Investigator's Global Assessment) ≥3) for at least 6 months
  • patient candidates for systemic therapy.
  • informed consent.

Exclusion criteria

  • previous treatment with agent targeting IL-17 (interleukine-17) or IL-17 receptor.
  • recent treatment with topical treatment (2 weeks), systemic agents (4 weeks for methotrexate, Ciclosporine A; systemic retinoids and other systemic treatment), TNF (tumor necrosis factor) inhibitors (3 months) or IL-12/23 inhibitors (6 months).

Treatment and study plan

secukinumab

Drug

weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.

Other names: open label, no other intervention

Primary outcomes

  1. proSPI (s) at Week 16 Compared to Baseline

    Time frame: Week 0 (baseline) to 16 weeks

    The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.

  2. Changes of saSPI (s) at Week 16 Compared to Baseline

    Time frame: Week 0 (baseline) to 16 weeks

    The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition

Secondary outcomes

  1. PASI (Psoriasis Area Severity Index) Score

    Time frame: week 0, 16, 52

    PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)

  2. Correlation Between PASI and proSPI (s)

    Time frame: week 0, 16, 52

    Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score

  3. proSPI (s, p and i) Over Time

    Time frame: weeks 0, 16, 52

    Professional Version of Simplified Psoriasis Index (proSPI)

    SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :

    • s for the severity, min =0 and max=50
    • p for the psychosocial, min=0 and max=10
    • i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure

  4. saSPI (s, p and i) Over Time

    Time frame: weeks 0, 16, 52

    Self-administered Simplified Psoriasis Index (saSPI)

    SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :

    • s for the severity, min =0 and max=50
    • p for the psychosocial, min=0 and max=10
    • i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure

  5. DLQI (Dermatology Life Quality Index) Over Time

    Time frame: weeks 0, 16, 52

    DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired

    MEANING OF DLQI SCORES 0 - 1 no effect on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life

  6. Self-administered PASI (SA-PASI)

    Time frame: weeks 0, 16, 52

    self-administered PASI (SA-PASI) score

  7. Psoriasis Symptom Diary (PSD) Score

    Time frame: weeks 0, 16, 52

    assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time

    PSD scores range from 0 to 10, with higher scores indicating a worse condition for each assessment: pain, itching and scaling

  8. Correlation Between proSPI (for Each Component: s, p and i) and DLQI

    Time frame: weeks 0, 16, 52

    Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below

  9. Correlation Between proSPI (for Components p and i) and PASI

    Time frame: Over time (from Week 0 to Week 52)

    Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis

Acronym: IPSI-PSO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2015
Registry last updated
Apr 17, 2019

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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