A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Drug: Deucravacitinib; Biological: Any biologic treatment for psoriasis

• Registration Number: NCT06952465
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to further evaluate the safety of deucravacitinib treatment in Japanese patients with psoriasis in the real-world setting

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-24
• Status Verified: 2025-04
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Primary Completion: 2031-11-30
• Study Completion: 2031-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Participants with prescriptions in deucravacitinib or any biologics as comparator group during the indexing period.
• Participants with at least one confirmed diagnosis of disease code for psoriasis within 12 months prior to the index date.
• Aged 18 years or older at the index date

Exclusion Criteria

• Participants with prescription in deucravacitinib or any biologics as comparator group prior to the index date.
• Participants with fewer than 12 months of available claim records prior to the index date.
• Participants with no claims record within 1-year after the index date (no visit after the index date).
• Specific for serious infection: Participants who had at least one disease code of hospitalized infection in the 60 days period before the index date.
• Specific for malignancy: Participants who had at least one disease code of malignancy prior to the index date

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Deucravacitinib	Participants receiving deucravacitinib treatment
Cohort 2	Any biologic treatment for psoriasis	Participants receiving biologics treatment for psoriasis

Primary Outcome Measures

Name	Time	Method
Participant baseline demographics	Baseline
Participant medical history	Baseline
Incidence of serious infections	Up to 9-years
Incidence of malignancies	Up to 9-years

Secondary Outcome Measures

Name	Time	Method
Incidence of serious infections excluding COVID-19	Up to 9-years
Incidence of serious infection of COVID-19	Up to 9-years
Incidence of opportunistic infections excluding tuberculosis and herpes zoster	Up to 9-years
Incidence of tuberculosis	Up to 9-years
Incidence of herpes zoster	Up to 9-years
Incidence of malignancies excluding non-melanoma skin cancer	Up to 9-years
Incidence of non-melanoma skin cancer	Up to 9-years
Incidence of solid tumors	Up to 9-years
Incidence of hematologic malignancies	Up to 9-years
Incidence of lymphoma	Up to 9-years

Trial Locations

Locations (2)

Local Institution; 🇯🇵 Tokyo, Japan

Medical Data Vision, Inc; 🇯🇵 Tokyo, Japan