A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)

May 15, 2026 updated by: Bristol-Myers Squibb

Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-world, Prospective, Observational Study of the Effectiveness of Deucravacitinib in Adults With Moderate-to-Severe Plaque Psoriasis in France

The purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens Picardie - Site Sud
        • Contact:
          • Ali Dadban, Site 060
          • Phone Number: 33322455841
      • Angers, France, 49100
        • Recruiting
        • Cabinet Médical Elisabeth Lion
        • Contact:
          • ANGELIQUE MARCHAND, Site 009
      • Argenteuil, France, 95107
        • Recruiting
        • Ch Victor Dupouy
        • Contact:
          • EMMANUEL MAHE, Site 045
      • Argenteuil, France, 95107
        • Completed
        • Local Institution - 089
      • Arras, France, 62000
        • Recruiting
        • CH Arras
        • Contact:
          • CELINE DESVIGNES, Site 010
      • Bordeaux, France, 33200
        • Recruiting
        • Cabinet Dermatologie
        • Contact:
          • CHRISTELLE PRUVOST BALLAND, Site 048
      • Chalon-sur-Saône, France, 71100
        • Recruiting
        • Centre Hospitalier William Morey - Hématologie
        • Contact:
          • MARIE DHERS, Site 001
      • Clermont-Ferrand, France, 63000
        • Completed
        • Local Institution - 053
      • Dijon, France, 21000
        • Recruiting
        • CHU Dijon
        • Contact:
          • Camille LELEU, Site 002
          • Phone Number: 33 3 80 29 33 36
      • Dijon, France, 21000
        • Not yet recruiting
        • Local Institution - 077
        • Contact:
          • Site 077
      • La Tronche, France, 38700
        • Recruiting
        • CHU Grenoble Alps, Service de Dermatologie
        • Contact:
          • Julie Charles, Site 011
          • Phone Number: +33476766493
      • Le Mans, France, 72037
        • Not yet recruiting
        • Local Institution - 014
        • Contact:
          • Site 014
      • Le Puy-en-Velay, France, 43000
        • Recruiting
        • CH Emile Roux
        • Contact:
          • CHARLINE GARCIA, Site 074
      • Lens, France, 62307
        • Recruiting
        • Centre Hospitalier Lens
        • Contact:
          • ELENA KARIMOVA, Site 039
      • Marcq-en-Barœul, France, 59700
        • Recruiting
        • Centre de santé Filieris
        • Contact:
          • MARION STEFANSKI, Site 004
      • Montpellier, France, 34295
        • Recruiting
        • Hopital Saint Eloi
        • Contact:
          • CELINE GIRARD, Site 036
      • Nice, France, 06000
        • Recruiting
        • Tagast 41
        • Contact:
          • Abdallah Khemis, Site 012
          • Phone Number: +33492036225
      • Niort, France, 79021
        • Recruiting
        • Ch Georges Renon
        • Contact:
          • JEREMY GOTTLIEB, Site 008
      • Nîmes, France, 30900
        • Recruiting
        • Hopital Caremeau
        • Contact:
          • BLANCHE BERGERET, Site 062
      • Paris, France, 75012
        • Recruiting
        • Cabinet de dermatologie
        • Contact:
          • MATHILDE KEMULA, Site 073
      • Paris, France, 75012
        • Completed
        • Local Institution - 086
      • Périgueux, France, 24000
        • Recruiting
        • Hôpital privé Francheville
        • Contact:
          • MARIE MASSON REGNAULT, Site 078
      • Roubaix, France, 59056
        • Recruiting
        • Centre Hospitalier de Roubaix
        • Contact:
          • SARAH JABRAN MAANAOUI, Site 047
      • Rouen, France, 76031
        • Completed
        • Local Institution - 031
      • Saint-Germain-en-Laye, France, 78100
        • Not yet recruiting
        • Local Institution - 065
        • Contact:
          • Site 065
      • Saint-Mandé, France, 94163
        • Recruiting
        • HIA Begin
        • Contact:
          • ANNE CLAIRE FOUGEROUSSE, Site 051
      • Saint-Maur-des-Fossés, France, 94100
        • Recruiting
        • Centre Dermatologique
        • Contact:
          • CHLOE CHARPENTIER, Site 072
      • Toulon, France, 83800
        • Recruiting
        • Hia Sainte Anne
        • Contact:
          • Thierry Boye, Site 055
          • Phone Number: 33483162916
      • Toulouse, France, 31059
        • Recruiting
        • Hopital Larrey
        • Contact:
          • Carle Paul, Site 005
          • Phone Number: +33567778140
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • Hopitaux de Brabois
        • Contact:
          • EMMANUELLE MELGAR, Site 064
      • Villeurbanne, France, 69100
        • Recruiting
        • Médipôle Hôpital Mutualiste
        • Contact:
          • XAVIER MARCELLIN, Site 006
  • Switzerland
      • La Chaux-de-Fonds, Switzerland, 2300
        • Recruiting
        • Cabinet Médical
        • Contact:
          • Mireille Ruer-Mulard, Site 007
          • Phone Number: +33442800590
      • La Chaux-de-Fonds, Switzerland, 2300
        • Completed
        • Local Institution - 056
      • La Chaux-de-Fonds, Switzerland, 2300
        • Completed
        • Local Institution - 059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients who have been diagnosed with moderate-to-severe plaque psoriasis and who intend to start deucravacitinib treatment in France

Description

Inclusion Criteria:

  • ≥18 years of age
  • Physician-reported diagnosis of moderate to severe plaque psoriasis
  • Be newly initiating deucravacitinib
  • Do not object to participate

Exclusion Criteria:

  • Currently participating in or planning to participate in an interventional clinical trial
  • Previous treatment experience with deucravacitinib, including patients who received deucravacitinib as part of a blinded, randomized trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants that have initiated deucravacitinib treatment
Drug: Deucravacitinib
As prescribed by treating clinician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Physician's Global Assessment (PGA) 0/1 response
Time Frame: Baseline and at months 4, 12, 18 (optional), and 24
Baseline and at months 4, 12, 18 (optional), and 24
Dermatology Life Quality Index (DLQI) 0/1 response
Time Frame: Baseline and at months 4, 12, 18 (optional), and 24
Baseline and at months 4, 12, 18 (optional), and 24
Time from date of treatment initiation to date of discontinuation
Time Frame: Up to 24 months
Up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment
Time Frame: Baseline and at months 4, 12, 18 (optional), and 24
Baseline and at months 4, 12, 18 (optional), and 24
Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Itch
Time Frame: Baseline and months 1, 4, 12, 18 (optional) and 24
Baseline and months 1, 4, 12, 18 (optional) and 24
Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS) - Skin pain
Time Frame: Baseline and months 1, 4, 12, 18 (optional) and 24
Baseline and months 1, 4, 12, 18 (optional) and 24
Change in patient reported symptom burden as assed by the 100-point Visual Analog Scale (VAS)] - Fatigue
Time Frame: Baseline and months 1, 4, 12, 18 (optional) and 24
Baseline and months 1, 4, 12, 18 (optional) and 24
Physician's Global Assessment (PGA) score change from start of deucravacitinib treatment to follow-up
Time Frame: Baseline and at months 4, 12, 18 (optional), and 24
Baseline and at months 4, 12, 18 (optional), and 24
Dermatology Life Quality Index (DLQI) score of ≤5
Time Frame: Baseline and at months 1, 4, 12 18 (optional) and 24
Baseline and at months 1, 4, 12 18 (optional) and 24
Body Surface Area (BSA) of ≤ 3%
Time Frame: Baseline and at months 4, 12, 18 (optional), and 24
Baseline and at months 4, 12, 18 (optional), and 24
Body Surface Area (BSA) of ≤ 1%
Time Frame: Baseline and at months 4, 12, 18 (optional), and 24
Baseline and at months 4, 12, 18 (optional), and 24
Reasons for deucravacitinib treatment discontinuation
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM011-1127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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