Overview

This trial is active, not recruiting.

Condition psoriasis
Treatment secukinumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date May 2015
End date January 2017
Trial size 120 participants
Trial identifier NCT02595970, CAIN457AFR01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Weekly sub cutaneous injections of 300 mg during the first month and then Monthly until Week 52 plus extension until 03/11/2016.
secukinumab
weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.

Primary Outcomes

Measure
Severity component(s) of the Simplified Psoriasis Index (SPI)
time frame: Change from baseline to 16 weeks

Secondary Outcomes

Measure
PASI (Psoriasis Area Severity Index) score
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
correlation between PASI and proSPI (s)
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
DLQI (Dermatology Life Quality Index)
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
SPI
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
correlation between proSPI and DLQI
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
Correlation between proSPI (p and i) and PASI
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
Self Administered PASI
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
Psoriasis Symptom Diary (pain, itching, scaling)
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, EOE and FU
Number of participants with treatment-related adverse events
time frame: week 0, 1, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 52, Extension Treatment Period, EOE and FU

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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).

Additional Information

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
Principal investigator PHILIPPE CELERIER
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Novartis.