- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06701513
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
Study Type
Observational
Enrollment (Estimated)
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
- 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
-
-
-
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
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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
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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
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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
- Hôpital 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
- Medipole Hopital Mutualiste
-
Contact:
- XAVIER MARCELLIN, Site 006
-
-
-
-
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La Chaux-de-Fonds, Switzerland, 2300
- Recruiting
- Cabinet Medical
-
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
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 |
Intervention / Treatment |
|---|---|
|
Participants that have initiated deucravacitinib treatment
|
As prescribed by treating clinician
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
January 29, 2025
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Study Registration Dates
First Submitted
November 20, 2024
First Submitted That Met QC Criteria
November 20, 2024
First Posted (Actual)
November 22, 2024
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 15, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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-
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-
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-
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