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

November 27, 2025 updated by: Bristol-Myers Squibb

"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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
Participants with moderate/severe psoriasis receiving deucravacitinib
Drug: Deucravacitinib
According to the product label

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The percentage of participants still receiving deucravacitinib treatment
Time Frame: Week 24 and 52
Week 24 and 52
Absolute Psoriasis Area and Severity Index (PASI)
Time Frame: Baseline and Weeks 16, 24 and 52
Baseline and Weeks 16, 24 and 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant sex
Time Frame: Baseline
Baseline
Participant height in cm
Time Frame: Baseline
Baseline
Participant comorbidities
Time Frame: Baseline
Baseline
Participant age in years
Time Frame: Baseline
Baseline
Participant body mass index in kg/m2
Time Frame: Baseline
Baseline
Participant previous pathologies
Time Frame: Baseline
Baseline
Participan previous surgical procedures
Time Frame: Baseline
Baseline
Date of psoriasis diagnosis
Time Frame: Baseline
Baseline
Number of participants with physical examination according to body systems
Time Frame: Baseline
Baseline
Participant treatment history
Time Frame: Baseline
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
Time Frame: Baseline and Weeks 16, 24 and 52
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
Baseline and Weeks 16, 24 and 52
Body Surface Area (BSA)
Time Frame: Baseline and Weeks 16, 24 and 52
Baseline and Weeks 16, 24 and 52
Static Physician's Global Assessment (sPGA) score
Time Frame: Baseline and Weeks 16, 24 and 52
Baseline and Weeks 16, 24 and 52
Scalp Specific Physician Global Assessment (ssPGA) score
Time Frame: Baseline and Weeks 16, 24 and 52
Baseline and Weeks 16, 24 and 52
Scalp Specific Physician Global Assessment (ssPGA) score 0/1
Time Frame: Baseline and Weeks 16, 24 and 52
Baseline and Weeks 16, 24 and 52
Absolute Psoriasis Area and Severity Index (PASI) 75 and 90
Time Frame: Baseline and Weeks 16, 24 and 52
Baseline and Weeks 16, 24 and 52
Concomitant psoriasis therapies received
Time Frame: Baseline and Weeks 16, 24 and 52
Baseline and Weeks 16, 24 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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