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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 (IPSI-PSO)

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Secukinumab

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Secukinumab, Simplified Psoriasis Index, CAIN457A, AIN457AFR01, AIN457A, Skin condition, skin disease, itching condition, psoriasis vulgaris, relapsing/remitting psoriasis, immune-mediated systemic disease, skin lesions, red skin lesions, scaly patches, papules, plaques, itching

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Secukinumab

Arm Description

Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016.

Outcomes

Primary Outcome Measures

proSPI (s) at Week 16 Compared to Baseline

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.

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

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 Outcome Measures

PASI (Psoriasis Area Severity Index) Score

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

Correlation Between PASI and proSPI (s)

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

proSPI (s, p and i) Over Time

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

saSPI (s, p and i) Over Time

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

DLQI (Dermatology Life Quality Index) Over Time

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

Self-administered PASI (SA-PASI)

self-administered PASI (SA-PASI) score

Psoriasis Symptom Diary (PSD) Score

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

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

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

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

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

Full Information

NCT ID

NCT02595970

First Posted

February 25, 2015

Last Updated

April 15, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02595970

Brief Title

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

Acronym

IPSI-PSO

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

May 20, 2015 (Actual)

Primary Completion Date

February 9, 2017 (Actual)

Study Completion Date

February 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis, Secukinumab, Simplified Psoriasis Index, CAIN457A, AIN457AFR01, AIN457A, Skin condition, skin disease, itching condition, psoriasis vulgaris, relapsing/remitting psoriasis, immune-mediated systemic disease, skin lesions, red skin lesions, scaly patches, papules, plaques, itching

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

This was an open label single-arm study; therefore treatment blinding was not necessary.

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab

Arm Type

Experimental

Arm Description

Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016.

Intervention Type

Drug

Intervention Name(s)

Secukinumab

Other Intervention Name(s)

open label, no other intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

proSPI (s) at Week 16 Compared to Baseline

Description

Time Frame

Week 0 (baseline) to 16 weeks

Title

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

Description

Time Frame

Week 0 (baseline) to 16 weeks

Secondary Outcome Measure Information:

Title

PASI (Psoriasis Area Severity Index) Score

Description

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

Time Frame

week 0, 16, 52

Title

Correlation Between PASI and proSPI (s)

Description

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

Time Frame

week 0, 16, 52

Title

proSPI (s, p and i) Over Time

Description

Time Frame

weeks 0, 16, 52

Title

saSPI (s, p and i) Over Time

Description

Time Frame

weeks 0, 16, 52

Title

DLQI (Dermatology Life Quality Index) Over Time

Description

Time Frame

weeks 0, 16, 52

Title

Self-administered PASI (SA-PASI)

Description

self-administered PASI (SA-PASI) score

Time Frame

weeks 0, 16, 52

Title

Psoriasis Symptom Diary (PSD) Score

Description

Time Frame

weeks 0, 16, 52

Title

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

Description

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

Time Frame

weeks 0, 16, 52

Title

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

Description

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

Time Frame

Over time (from Week 0 to Week 52)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials: