A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

NCT ID: NCT06382987

Last Updated: 2024-04-25

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

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-22

Study Completion Date

2029-12-31

Brief Summary

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This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants that have initiated deucravacitinib treatment

Deucravacitinib

Intervention Type DRUG

According to the product label

Participants that have initiated apremilast treatment

Apremilast

Intervention Type DRUG

According to the product label

Interventions

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Deucravacitinib

According to the product label

Intervention Type DRUG

Apremilast

According to the product label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese adult participants aged 18 years old or older
* Physician-reported diagnosis of plaque psoriasis
* Newly initiating deucravacitinib or apremilast according to the label
* Participants who have signed informed consent

Exclusion Criteria

* Participants currently participating in or planning to participate in an interventional clinical trial
* Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264)
* Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)
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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Mebix. Inc.

Minato-ku, Tokyo, Japan

Site Status RECRUITING

Fukuoka University Hospital

Fukuoka, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

855-907-3286

First line of the email MUST contain NCT # and Site #.

Role: CONTACT

Facility Contacts

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Minoru Tonogai, Site 0001

Role: primary

Related Links

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Other Identifiers

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IM011-1124

Identifier Type: -

Identifier Source: org_study_id

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