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

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595970
• Other study ID #: CAIN457AFR01
• Status: Completed
• Phase: Phase 3
• Start date: May 20, 2015
• Est. completion date: February 9, 2017

Study information

• Verified date: April 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 9, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
France	Novartis Investigative Site	Amiens Cedex 1
France	Novartis Investigative Site	Antony
France	Novartis Investigative Site	Argenteuil
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	La Rochelle
France	Novartis Investigative Site	Le Mans	Cedex 09
France	Novartis Investigative Site	Limoges cedex	Haute Vienne
France	Novartis Investigative Site	Marseille Cedex 05
France	Novartis Investigative Site	Martigues
France	Novartis Investigative Site	Metz
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Rouen
France	Novartis Investigative Site	Toulon Cedex 9	Val De Marne
France	Novartis Investigative Site	Toulouse Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 0 (baseline) to 16 weeks
Primary	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	Week 0 (baseline) to 16 weeks
Secondary	PASI (Psoriasis Area Severity Index) Score	PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)	week 0, 16, 52
Secondary	Correlation Between PASI and proSPI (s)	Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score	week 0, 16, 52
Secondary	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	weeks 0, 16, 52
Secondary	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	weeks 0, 16, 52
Secondary	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	weeks 0, 16, 52
Secondary	Self-administered PASI (SA-PASI)	self-administered PASI (SA-PASI) score	weeks 0, 16, 52
Secondary	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	weeks 0, 16, 52
Secondary	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	weeks 0, 16, 52
Secondary	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	Over time (from Week 0 to Week 52)