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NCT Number: NCT07256015

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Integrata Di Verona

Verona, 37126, Italy

Location status: Recruiting

Location contact

Paolo Gisondi, Site 0001

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deucravacitinib

Drug

According to the product label

Primary outcomes

  1. The percentage of participants still receiving deucravacitinib treatment

    Time frame: Week 24 and 52

  2. Absolute Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline and Weeks 16, 24 and 52

Secondary outcomes

  1. Participant age in years

    Time frame: Baseline

  2. Participant sex

    Time frame: Baseline

  3. Participant height in cm

    Time frame: Baseline

  4. Participant body mass index in kg/m2

    Time frame: Baseline

  5. Participant previous pathologies

    Time frame: Baseline

  6. Participan previous surgical procedures

    Time frame: Baseline

  7. Date of psoriasis diagnosis

    Time frame: Baseline

  8. Number of participants with physical examination according to body systems

    Time frame: Baseline

  9. 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

  10. Participant comorbidities

    Time frame: Baseline

  11. Quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire

    Time frame: Baseline and Weeks 16, 24 and 52

  12. Change in symptoms as assessed by the Itch Numerical Rating Scale (Itch-NRS) score

    Time frame: Baseline and Weeks 16, 24 and 52

  13. Body Surface Area (BSA)

    Time frame: Baseline and Weeks 16, 24 and 52

  14. Static Physician's Global Assessment (sPGA) score

    Time frame: Baseline and Weeks 16, 24 and 52

  15. Scalp Specific Physician Global Assessment (ssPGA) score

    Time frame: Baseline and Weeks 16, 24 and 52

  16. Scalp Specific Physician Global Assessment (ssPGA) score 0/1

    Time frame: Baseline and Weeks 16, 24 and 52

  17. Absolute Psoriasis Area and Severity Index (PASI) 75 and 90

    Time frame: Baseline and Weeks 16, 24 and 52

  18. Concomitant psoriasis therapies received

    Time frame: Baseline and Weeks 16, 24 and 52

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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