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NCT Number: NCT06952465

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deucravacitinib

Drug

As per product label

Any biologic treatment for psoriasis

Biological

According to the product label

Primary outcomes

  1. Participant baseline demographics

    Time frame: Baseline

  2. Participant medical history

    Time frame: Baseline

  3. Incidence of serious infections

    Time frame: Up to 9-years

  4. Incidence of malignancies

    Time frame: Up to 9-years

Secondary outcomes

  1. Incidence of serious infections excluding COVID-19

    Time frame: Up to 9-years

  2. Incidence of serious infection of COVID-19

    Time frame: Up to 9-years

  3. Incidence of opportunistic infections excluding tuberculosis and herpes zoster

    Time frame: Up to 9-years

  4. Incidence of tuberculosis

    Time frame: Up to 9-years

  5. Incidence of herpes zoster

    Time frame: Up to 9-years

  6. Incidence of malignancies excluding non-melanoma skin cancer

    Time frame: Up to 9-years

  7. Incidence of non-melanoma skin cancer

    Time frame: Up to 9-years

  8. Incidence of solid tumors

    Time frame: Up to 9-years

  9. Incidence of hematologic malignancies

    Time frame: Up to 9-years

  10. Incidence of lymphoma

    Time frame: Up to 9-years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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