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Recruiting NCT07256015

Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy

— Observational Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deucravacitinib.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

"DEMOS" - Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy

Overview

The purpose of this study is to characterize the real-life experience of patients with moderate/severe psoriasis receiving deucravacitinib treatment, in terms of efficacy, safety, and health-related quality of life (HRQoL) in Italy

Interventions

  • Drug Deucravacitinib
    According to the product label

Primary outcome measures

  • The percentage of participants still receiving deucravacitinib treatment [Time frame: Week 24 and 52]
  • Absolute Psoriasis Area and Severity Index (PASI) [Time frame: Baseline and Weeks 16, 24 and 52]
Secondary outcome measures (12)
  • Participant age in years [Time frame: Baseline]
  • Participant sex [Time frame: Baseline]
  • Participant height in cm [Time frame: Baseline]
  • Participant body mass index in kg/m2 [Time frame: Baseline]
  • Participant previous pathologies [Time frame: Baseline]
  • Participan previous surgical procedures [Time frame: Baseline]
  • Date of psoriasis diagnosis [Time frame: Baseline]
  • Number of participants with physical examination according to body systems [Time frame: Baseline]
  • Participant treatment history [Time frame: Baseline]
  • Participant comorbidities [Time frame: Baseline]
  • Quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire [Time frame: Baseline and Weeks 16, 24 and 52]
  • Change in symptoms as assessed by the Itch Numerical Rating Scale (Itch-NRS) score [Time frame: Baseline and Weeks 16, 24 and 52]

Eligibility criteria

Inclusion criteria

  • Participants have initiated treatment with deucravacitinib monotherapy 4 to 8 weeks earlier according to clinical practice and to reimbursement criteria determined by National Drug Agency in Italy (AIFA)
  • Patients have moderate to severe plaque psoriasis
  • Patients have signed informed consent form (ICF)

Exclusion criteria

  • Simultaneous participation in any interventional study for their moderate-to-severe psoriasis
  • Inability to participate to the study for the following reasons: patients unable to understand the aim of the study, patients unable to understand and sign the ICF

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Azienda Ospedaliera Universitaria Integrata Di Verona — Verona

Identifiers

NCT: NCT07256015 · IM011-1228

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗