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

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

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 Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Deucravacitinib

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #

Study Locations

• Italy
  • Verona
    • Verona, Verona, Italy, 37126
      • Recruiting
      • Azienda Ospedaliera Universitaria Integrata di Verona
      • Contact: Paolo Gisondi, Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults diagnosed moderate/severe psoriasis who have already started treatment with deucravacitinib according to clinical practice and to reimbursement criteria determined by the National Drug Agency (AIFA) in Italy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Participants with moderate/severe psoriasis receiving deucravacitinib	Drug: Deucravacitinib; According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of participants still receiving deucravacitinib treatment	Week 24 and 52
Absolute Psoriasis Area and Severity Index (PASI)	Baseline and Weeks 16, 24 and 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant sex		Baseline
Participant height in cm		Baseline
Participant comorbidities		Baseline
Participant age in years		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	Treatment history to describe participants previous treatment(s) received for psoriasis and participants previous treatment(s) received not related to psoriasis	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): August 5, 2027

Study Registration Dates

• First Submitted: August 28, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Moderate/Severe Psoriasis
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Skin Diseases, Papulosquamous; Skin Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Psoriasis; Lymphoma, Follicular; deucravacitinib
• Other Study ID Numbers: IM011-1228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No