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

A Cohort Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis Using Administrative Health Claims Database

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06952465

Enrollment

2000

Registered

2025-05-01

Start date

2025-01-24

Completion date

2031-11-30

Last updated

2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis (PsO)

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

Interventions

DRUGDeucravacitinib

As per product label

BIOLOGICALAny biologic treatment for psoriasis

According to the product label

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Incidence of hematologic malignancies	Up to 9-years
Incidence of lymphoma	Up to 9-years
Incidence of serious infections excluding COVID-19	Up to 9-years
Incidence of herpes zoster	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 serious infection of COVID-19	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026