NCT05633264

Brief Summary

The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

November 22, 2022

Last Update Submit

July 2, 2025

Conditions

Psoriasis

Keywords

PsoriasisDeucravacitinib

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events (AEs)

    Up to 52 weeks

Secondary Outcomes (8)

  • Proportion of participants achieving Static Physicians Global Assessment (sPGA) of 0/1 during study period

    Up to 52 weeks

  • Change from Baseline in Body Surface Area (BSA) during study period

    Up to 52 weeks

  • Proportion of participants achieving Global Improvement Score (GIS) during study period

    Up to 52 weeks

  • Distribution of demographic characteristics: Age

    Up to 52 weeks

  • Distribution of demographic characteristics: Sex

    Up to 52 weeks

  • +3 more secondary outcomes

Study Arms (1)

Cohort 1

Psoriasis (PsO) participants who initiate treatment with Deucravacitinib.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of Psoriasis (PsO) participants (participants with plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis) who initiate treatment with Deucravacitinib will be enrolled. Participants receiving Deucravacitinib for an off label indication will be excluded.

You may qualify if:

  • Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS

You may not qualify if:

  • Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EP Pharmaline

Tosima-ku, Tokyo, 171-0021, Japan

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 1, 2022

Study Start

December 5, 2022

Primary Completion

May 28, 2025

Study Completion

May 28, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Locations

JP(1)