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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06382987
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

: Participants that have initiated deucravacitinib treatment

: Participants that have initiated apremilast treatment

Interventions

Drug: - Deucravacitinib

According to the product label

Drug: - Apremilast

According to the product label

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Mebix. Inc., Minato-ku, Tokyo, Japan

Status

Recruiting

Address

Mebix. Inc.

Minato-ku, Tokyo, 1070052

Site Contact

Minoru Tonogai, Site 0001

Clinical.Trials@bms.com

855-907-3286

Fukuoka University Hospital, Fukuoka, Japan

Status

Recruiting

Address

Fukuoka University Hospital

Fukuoka, ,

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