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

NCT07256015 | Recruiting FDA Drug

• 1 other identifier: IM011-1228
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriasis

Keywords

Moderate/Severe Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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

Study Arms (1)

Cohort 1

Participants with moderate/severe psoriasis receiving deucravacitinib

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

According to the product label

Cohort 1

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, Verona, 37126, Italy

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis; Lymphoma, Follicular

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: December 1, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): July 5, 2027
• Study Completion (Estimated): August 5, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)