PsoriasisNCT07256015
Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Deucravacitinib
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 5 Aug 2025to 5 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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
- Conditions
- Psoriasis
- Being tested
- Deucravacitinib
- Keywords
- Moderate/Severe Psoriasis
- Medical subject headings
- Psoriasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with moderate/severe psoriasis receiving deucravacitinib Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants still receiving deucravacitinib treatment
Measured: Week 24 and 52
Absolute Psoriasis Area and Severity Index (PASI)
Measured: Baseline and Weeks 16, 24 and 52
Secondary outcomes (18)
Participant age in years
Measured: Baseline
Participant sex
Measured: Baseline
Participant height in cm
Measured: Baseline
Participant body mass index in kg/m2
Measured: Baseline
Participant previous pathologies
Measured: Baseline
Participan previous surgical procedures
Measured: Baseline
Date of psoriasis diagnosis
Measured: Baseline
Number of participants with physical examination according to body systems
Measured: 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
Measured: Baseline
Participant comorbidities
Measured: Baseline
Quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire
Measured: Baseline and Weeks 16, 24 and 52
Change in symptoms as assessed by the Itch Numerical Rating Scale (Itch-NRS) score
Measured: Baseline and Weeks 16, 24 and 52
Body Surface Area (BSA)
Measured: Baseline and Weeks 16, 24 and 52
Static Physician's Global Assessment (sPGA) score
Measured: Baseline and Weeks 16, 24 and 52
Scalp Specific Physician Global Assessment (ssPGA) score
Measured: Baseline and Weeks 16, 24 and 52
Scalp Specific Physician Global Assessment (ssPGA) score 0/1
Measured: Baseline and Weeks 16, 24 and 52
Absolute Psoriasis Area and Severity Index (PASI) 75 and 90
Measured: Baseline and Weeks 16, 24 and 52
Concomitant psoriasis therapies received
Measured: Baseline and Weeks 16, 24 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start5 Aug 2025
- Primary completion5 Jul 2027 (estimated)
- Study completion5 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers SquibbBristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256015
- Sponsor's protocol ID
- IM011-1228
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "DEMOS" - Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
- ClinicalTrials.gov ID
- NCT07256015
- Acronym / sponsor ID
- IM011-1228
- Conditions
- Psoriasis
- Keywords
- Moderate/Severe Psoriasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 5 Jul 2027 (estimated)
- Study completion
- 5 Aug 2027 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: DeucravacitinibParticipants with moderate/severe psoriasis receiving deucravacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeucravacitinibAccording to the product label | Drug | Cohort 1 |
Primary outcome
The percentage of participants still receiving deucravacitinib treatment
Time frame: Week 24 and 52
Absolute Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and Weeks 16, 24 and 52
18 secondary outcomes
Participant age in years
Time frame: Baseline
Participant sex
Time frame: Baseline
Participant height in cm
Time frame: Baseline
Participant body mass index in kg/m2
Time frame: Baseline
Participant previous pathologies
Time frame: Baseline
Participan previous surgical procedures
Time frame: Baseline
Date of psoriasis diagnosis
Time frame: Baseline
Number of participants with physical examination according to body systems
Time frame: Baseline
Participant treatment history
Time frame: Baseline
Participant comorbidities
Time frame: Baseline
Quality of life as assessed by the Dermatology Life Quality Index (DLQI) questionnaire
Time frame: 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
Body Surface Area (BSA)
Time frame: Baseline and Weeks 16, 24 and 52
Static Physician's Global Assessment (sPGA) score
Time frame: Baseline and Weeks 16, 24 and 52
Scalp Specific Physician Global Assessment (ssPGA) score
Time frame: 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
Absolute Psoriasis Area and Severity Index (PASI) 75 and 90
Time frame: Baseline and Weeks 16, 24 and 52
Concomitant psoriasis therapies received
Time frame: Baseline and Weeks 16, 24 and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of participants still receiving deucravacitinib treatment (time frame: Week 24 and 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.