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

NCT02595970 | Completed Phase 3 Results

• 1 other identifier: CAIN457AFR01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 17

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• PASI (Psoriasis Area Severity Index) Score

  week 0, 16, 52

• Correlation Between PASI and proSPI (s)

  week 0, 16, 52

• proSPI (s, p and i) Over Time

  weeks 0, 16, 52

• saSPI (s, p and i) Over Time

  weeks 0, 16, 52

• DLQI (Dermatology Life Quality Index) Over Time

  weeks 0, 16, 52

Study Arms (1)

Secukinumab

EXPERIMENTAL

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

Drug: Secukinumab

Interventions

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.

Also known as: open label, no other intervention

Secukinumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Le Mans, Cedex 09, 72037, France

Location

Novartis Investigative Site

Limoges, Haute Vienne, 87000, France

Location

Novartis Investigative Site

Toulon, Val De Marne, 83800, France

Location

Novartis Investigative Site

Amiens, 80054, France

Location

Novartis Investigative Site

Antony, 92160, France

Location

Novartis Investigative Site

Argenteuil, 95107, France

Location

Novartis Investigative Site

Bordeaux, 33076, France

Location

Novartis Investigative Site

Brest, 29609, France

Location

Novartis Investigative Site

La Rochelle, 17019, France

Location

Novartis Investigative Site

Marseille, 13885, France

Location

Novartis Investigative Site

Martigues, 13500, France

Location

Novartis Investigative Site

Metz, 57077, France

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

Novartis Investigative Site

Paris, 75877, France

Location

Novartis Investigative Site

Rouen, 76031, France

Location

Novartis Investigative Site

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Psoriasis; Skin Diseases; Recurrence; Plaque, Amyloid; Pruritus

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Skin Manifestations; Signs and Symptoms

Limitations and Caveats

The two deaths (i.e.; head injury and lymphoma) were not related to the study treatment

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

+1(862)778-8300

Study Officials

• PHILIPPE CELERIER

  HOPITAL SAINT LOUIS - LA ROCHELLE

  PRINCIPAL INVESTIGATOR

• MARIE-ALETH RICHARD

  HOPITAL TIMONES - MARSEILLE

  PRINCIPAL INVESTIGATOR

• SELIM ARACTINGI

  HOPITAL COCHIN - PARIS

  PRINCIPAL INVESTIGATOR

• PIERRE ANDRE BECHEREL

  HOPITAL PRIVE D'ANTONY - ANTONY

  PRINCIPAL INVESTIGATOR

• EMMANUEL MAHE

  CH VICTOR DUPOUY - ARGENTEUIL

  PRINCIPAL INVESTIGATOR

• PHILIPPE LACOUR

  HOPITAL L'ARCHET - NICE

  PRINCIPAL INVESTIGATOR

• MIREILLE RUER MULARD

  CABINET BATEAU BLANC - MARTIGUES

  PRINCIPAL INVESTIGATOR

• THIERRY BOYE

  HIA SAINTE ANNE - TOULON

  PRINCIPAL INVESTIGATOR

• ANNE DUVAL-MODESTE

  HOPITAL CHARLES NICOLLE - ROUEN

  PRINCIPAL INVESTIGATOR

• MARIE BEYLOT-BARRY

  HOPITAL SAINT ANDRE - BORDEAUX

  PRINCIPAL INVESTIGATOR

• LAURENT MISERY

  HOPITAL MORVAN - BREST

  PRINCIPAL INVESTIGATOR

• VINCENT DESCAMPS

  HOPITAL BICHAT CLAUDE BERNARD - PARIS

  PRINCIPAL INVESTIGATOR

• GUILLAUME CHABY

  CHU AMIENS NORD - AMIENS

  PRINCIPAL INVESTIGATOR

• CARLE PAUL

  HOPITAL LARREY - TOULOUSE

  PRINCIPAL INVESTIGATOR

• CHRISTOPHE BEDANE

  HOPITAL DUPUYTREN - LIMOGES

  PRINCIPAL INVESTIGATOR

• HERVÉ MAILLARD

  CENTRE HOSPITALIER LE MANS - LE MANS

  PRINCIPAL INVESTIGATOR

• JEAN-FRANCOIS CUNY

  HIA LEGOUEST - METZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: This was an open label single-arm study; therefore treatment blinding was not necessary.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: November 4, 2015
• Study Start: May 20, 2015
• Primary Completion: February 9, 2017
• Study Completion: February 9, 2017
• Last Updated: April 17, 2019
• Results First Posted: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)