Deucravacitinib for moderate-to-severe plaque psoriasis — real-life experience in Italy
"DEMOS" - Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
This project will try to see how well deucravacitinib works, how safe it is, and how it affects quality of life for people in Italy with moderate-to-severe plaque psoriasis who started the medicine 4 to 8 weeks ago.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | deucravacitinib |
| Locations | 1 site (Verona, Verona) |
| Trial ID | NCT07256015 on ClinicalTrials.gov |
What this trial studies
This observational, single-center project in Verona follows patients with moderate-to-severe plaque psoriasis who initiated deucravacitinib monotherapy 4–8 weeks earlier in routine clinical practice. Investigators will record clinical skin response, adverse events, and health-related quality of life using standard clinical measures and patient-reported outcomes during follow-up visits. Patients already enrolled in interventional psoriasis trials or unable to consent are excluded. The aim is to provide real-world data on effectiveness and tolerability complementary to randomized trial results.
Who should consider this trial
Good fit: Patients in Italy with moderate-to-severe plaque psoriasis who began deucravacitinib monotherapy 4–8 weeks before enrollment and can give informed consent are ideal candidates.
Not a fit: People who have not started deucravacitinib, who are on combination psoriasis therapies, or who cannot understand or sign informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could confirm that deucravacitinib improves skin symptoms and quality of life while having an acceptable safety profile for patients treated in routine Italian practice.
How similar studies have performed: Randomized phase 3 trials have shown deucravacitinib is effective for plaque psoriasis, while real-world evidence is still limited but increasing.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Verona, Verona
- Azienda Ospedaliera Universitaria Integrata Di Verona — Verona, Verona, Italy (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.