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

NCT ID: NCT06952465

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-24

Study Completion Date

2031-11-30

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

Participants receiving deucravacitinib treatment

Deucravacitinib

Intervention Type DRUG

As per product label

Cohort 2

Participants receiving biologics treatment for psoriasis

Any biologic treatment for psoriasis

Intervention Type BIOLOGICAL

According to the product label

Interventions

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Deucravacitinib

As per product label

Intervention Type DRUG

Any biologic treatment for psoriasis

According to the product label

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Tokyo, , Japan

Site Status

Medical Data Vision, Inc

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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IM011-227

Identifier Type: -

Identifier Source: org_study_id

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