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

NCT06952465 | Active Not Recruiting FDA Drug

• 1 other identifier: IM011-227
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

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

Conditions

Psoriasis

Keywords

Psoriasis (PsO)

Outcome Measures

Primary Outcomes (4)

• Participant baseline demographics

  Baseline

• Participant medical history

  Baseline

• Incidence of serious infections

  Up to 9-years

• Incidence of malignancies

  Up to 9-years

Secondary Outcomes (10)

• 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

Study Arms (2)

Cohort 1

Participants receiving deucravacitinib treatment

Drug: Deucravacitinib

Cohort 2

Participants receiving biologics treatment for psoriasis

Biological: Any biologic treatment for psoriasis

Interventions

Deucravacitinib DRUG

As per product label

Cohort 1

Any biologic treatment for psoriasis BIOLOGICAL

According to the product label

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients identified from the Japanese healthcare claims database with psoriasis who have initiated either deucravacitinib or any biologic treatment for psoriasis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Tokyo, 171-0021, Japan

Location

Medical Data Vision, Inc

Tokyo, Japan

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 1, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): November 30, 2031
• Study Completion (Estimated): November 30, 2031
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)