NCT07256015RecruitingNot Applicable
"DEMOS" - Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
Bristol-Myers Squibb1 site in 1 country200 target enrollmentStarted: August 5, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The percentage of participants still receiving deucravacitinib treatment
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cohort 1
Participants with moderate/severe psoriasis receiving deucravacitinib
Intervention: Deucravacitinib (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Participant age in years(Baseline)
- Participant sex(Baseline)
- Participant height in cm(Baseline)
- Participant body mass index in kg/m2(Baseline)
- Participant previous pathologies(Baseline)
- Participan previous surgical procedures(Baseline)
- Date of psoriasis diagnosis(Baseline)
- Number of participants with physical examination according to body systems(Baseline)
- Participant treatment history(Baseline)
- Participant comorbidities(Baseline)
- Quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire(Baseline and Weeks 16, 24 and 52)
- Change in symptoms as assessed by the Itch Numerical Rating Scale (Itch-NRS) score(Baseline and Weeks 16, 24 and 52)
- Body Surface Area (BSA)(Baseline and Weeks 16, 24 and 52)
- Static Physician's Global Assessment (sPGA) score(Baseline and Weeks 16, 24 and 52)
- Scalp Specific Physician Global Assessment (ssPGA) score(Baseline and Weeks 16, 24 and 52)
- Scalp Specific Physician Global Assessment (ssPGA) score 0/1(Baseline and Weeks 16, 24 and 52)
- Absolute Psoriasis Area and Severity Index (PASI) 75 and 90(Baseline and Weeks 16, 24 and 52)
- Concomitant psoriasis therapies received(Baseline and Weeks 16, 24 and 52)
Investigators
Study Sites (1)
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