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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02595970

Acronym

IPSI-PSO

Enrollment

120

Registered

2015-11-04

Start date

2015-05-20

Completion date

2017-02-09

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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

Interventions

DRUGSecukinumab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
proSPI (s) at Week 16 Compared to Baseline	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.
Changes of saSPI (s) at Week 16 Compared to Baseline	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

Measure	Time frame	Description
proSPI (s, p and i) Over Time	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
saSPI (s, p and i) Over Time	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
DLQI (Dermatology Life Quality Index) Over Time	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
PASI (Psoriasis Area Severity Index) Score	week 0, 16, 52	PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)
Psoriasis Symptom Diary (PSD) Score	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
Correlation Between proSPI (for Each Component: s, p and i) and DLQI	weeks 0, 16, 52	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	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
Self-administered PASI (SA-PASI)	weeks 0, 16, 52	self-administered PASI (SA-PASI) score
Correlation Between PASI and proSPI (s)	week 0, 16, 52	Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score

Countries

France

Participant flow

Recruitment details

Study centers: This study involved 17 active centers who enrolled (or recruited) patients in France First patient enrolled: 20-May-2015 Last patient completed: 09-Feb-2017

Pre-assignment details

No significant events in the study (for example, wash out, run-in) that occur after participant enrollment, but prior to assignment of participants to the treatment arm

Participants by arm

Arm	Count
Single Arm Secukinumab Weekly injections of 300mg of secukinumab during the first month (induction period), followed by monthly injections thereafter to week 48. During this extension period, patients continued to receive monthly injections until End of Extension visit.	120
Total	120

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	5
Overall Study	Lack of Efficacy	7
Overall Study	Physician Decision	2
Overall Study	Protocol Violation	4
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Single Arm Secukinumab
Age, Continuous	45.9 years STANDARD_DEVIATION 14.17
proSPI (s)	24.9 scores on a scale STANDARD_DEVIATION 10.71
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	116 Participants
saSPI (s)	23.5 score on a scale for each domain of SPI STANDARD_DEVIATION 10.37
Sex: Female, Male Female	37 Participants
Sex: Female, Male Male	83 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	2 / 120
other Total, other adverse events	86 / 120
serious Total, serious adverse events	13 / 120

Outcome results

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

Time frame: Week 0 (baseline) to 16 weeks

Population: Full Analysis Set (FAS): The FAS comprised all patients from the IS who were administered at least one dose of investigational drug with at least one Baseline and one post-baseline SPI evaluation.

Arm	Measure	Group	Value (MEAN)	Dispersion
Single Arm Secukinumab	Changes of saSPI (s) at Week 16 Compared to Baseline	W0	23.54 scores on a scale	Standard Deviation 10.412
Single Arm Secukinumab	Changes of saSPI (s) at Week 16 Compared to Baseline	W16	1.99 scores on a scale	Standard Deviation 4.508

p-value: <0.000195% CI: [-23.52, 19.58]t-test, 2 sided

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.

Time frame: Week 0 (baseline) to 16 weeks

Population: The primary analysis was performed on the FAS. To assess for robustness of the results, the primary analysis was repeated for the FAS (on observed data).

Arm	Measure	Group	Value (MEAN)	Dispersion
Single Arm Secukinumab	proSPI (s) at Week 16 Compared to Baseline	W0	24.89 scores on a scale	Standard Deviation 10.747
Single Arm Secukinumab	proSPI (s) at Week 16 Compared to Baseline	W16	2.34 scores on a scale	Standard Deviation 6.144

p-value: <0.000195% CI: [-24.52, 20.59]t-test, 2 sided

Secondary