Deucravacitinib for Patients With Moderate/Severe Psorias... | NCT07256015

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

NCT07256015

Sponsor

Bristol-Myers Squibb

Status

Recruiting

Last Update Posted

Dec 1, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Psoriasis

Interventions

Deucravacitinib

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2025Actual

Primary Completion Date

Jul 5, 2027Estimated

Completion Date

Aug 5, 2027Estimated

First Submitted Date

Aug 28, 2025

First Submission Date that Met QC Criteria

Nov 27, 2025

First Posted Date

Dec 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2025

Last Update Posted Date

Dec 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		Participants with moderate/severe psoriasis receiving deucravacitinib	Drug: Deucravacitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deucravacitinib	Drug	According to the product label	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Participant age in years		Baseline
Participant sex		Baseline
Participant height in cm

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Bristol Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera Universitaria Integrata Di Verona	Recruiting	Verona	Verona	37126	Italy

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

ID	Term
D011565	Psoriasis
D008224	Lymphoma, Follicular

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D008228	Lymphoma, Non-Hodgkin