PsoriasisNCT06701513
A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)
An observational study of Psoriasis, run by Bristol-Myers Squibb at 48 sites in 2 countries.
Trial summary
The purpose of this study is to assess the real-world effectiveness of deucravacitinib treatment in adults diagnosed with moderate-to-severe plaque psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Deucravacitinib
- How many people
- 350 participants
- Where
- 48 sitesin 2 countries
- Study dates
- 29 Jan 2025to 30 Apr 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients who have been diagnosed with moderate-to-severe plaque psoriasis and who intend to start deucravacitinib treatment in France
Who may be able to join
- ≥18 years of age
- Physician-reported diagnosis of moderate to severe plaque psoriasis
- Be newly initiating deucravacitinib
- Do not object to participate
Who cannot join
- 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
Trial locations and contacts
48 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
48 sites in 2 countries
France39 sites, 35 recruiting
- Recruiting
Chu Amiens Picardie - Site Sud
Amiens, 80054
Ali Dadban, Site 060, 33322455841
- Recruiting
Cabinet Médical Elisabeth Lion
Angers, 49100
ANGELIQUE MARCHAND, Site 009
- Recruiting
Ch Victor Dupouy
Argenteuil, 95107
EMMANUEL MAHE, Site 045
- Completed
Local Institution - 089
Argenteuil, 95107
- Recruiting
CH ARRAS
Arras, 62000
CELINE DESVIGNES, Site 010
- Recruiting
Cabinet Dermatologie
Bordeaux, 33200
VALERIE DORIZY-VUONG, Site 041
- Recruiting
Cabinet Dermatologie
Bordeaux, 33200
CHRISTELLE PRUVOST BALLAND, Site 048
- Recruiting
Centre Hospitalier William Morey - Hématologie
Chalon-sur-Saône, 71100
MARIE DHERS, Site 001
- Completed
Local Institution - 053
Clermont-Ferrand, 63000
- Recruiting
CHU Dijon
Dijon, 21000
Camille LELEU, Site 002, 33 3 80 29 33 36
- Not yet recruiting
Local Institution - 077
Dijon, 21000
Site 077
- Recruiting
CHU Grenoble Alps, Service de Dermatologie
La Tronche, 38700
Julie Charles, Site 011, +33476766493
- Not yet recruiting
Local Institution - 014
Le Mans, 72037
Site 014
- Recruiting
CH Emile Roux
Le Puy-en-Velay, 43000
CHARLINE GARCIA, Site 074
- Recruiting
Centre Hospitalier Lens
Lens, 62307
ELENA KARIMOVA, Site 039
- Recruiting
Centre de santé Filieris
Marcq-en-Barœul, 59700
MARION STEFANSKI, Site 004
- Recruiting
Hopital Saint Eloi
Montpellier, 34295
CELINE GIRARD, Site 036
- Recruiting
Tagast 41
Nice, 06000
Abdallah Khemis, Site 012, +33492036225
- Recruiting
Hopital Caremeau
Nîmes, 30900
BLANCHE BERGERET, Site 062
- Recruiting
Ch Georges Renon
Niort, 79021
CAROLINE JADE CLERC, Site 070
- Recruiting
Ch Georges Renon
Niort, 79021
JEREMY GOTTLIEB, Site 008
- Recruiting
Cabinet de dermatologie
Paris, 75012
MATHILDE KEMULA, Site 073
- Completed
Local Institution - 086
Paris, 75012
- Recruiting
Hôpital Privé Francheville
Périgueux, 24000
MARIE MASSON REGNAULT, Site 078
- Recruiting
Centre Hospitalier de Roubaix
Roubaix, 59056
OLIVIER CARPENTIER, Site 046
- Recruiting
Centre Hospitalier de Roubaix
Roubaix, 59056
SARAH JABRAN MAANAOUI, Site 047
- Completed
Local Institution - 031
Rouen, 76031
- Not yet recruiting
Local Institution - 065
Saint-Germain-en-Laye, 78100
Site 065
- Recruiting
Hia Begin
Saint-Mandé, 94163
ANNE CLAIRE FOUGEROUSSE, Site 051
- Recruiting
Centre Dermatologique
Saint-Maur-des-Fossés, 94100
CHLOE CHARPENTIER, Site 072
- Recruiting
Hia Sainte Anne
Toulon, 83800
AUDE VALOIS, Site 054
- Recruiting
Hia Sainte Anne
Toulon, 83800
Thierry Boye, Site 055, 33483162916
- Recruiting
Hopital Larrey
Toulouse, 31059
MAELLA SEVERINO FREIRE, Site 037
- Recruiting
Hopital Larrey
Toulouse, 31059
Cristina Livideanu, Site 021, +33567771452
- Recruiting
Hopital Larrey
Toulouse, 31059
Carle Paul, Site 005, +33567778140
- Recruiting
Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511
ANNE CLAIRE BURSZTEJN, Site 061
- Recruiting
Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511
EMMANUELLE MELGAR, Site 064
- Recruiting
Médipôle Hôpital Mutualiste
Villeurbanne, 69100
CATHERINE GOUJON-HENRY, Site 003
- Recruiting
Médipôle Hôpital Mutualiste
Villeurbanne, 69100
XAVIER MARCELLIN, Site 006
Switzerland9 sites, 7 recruiting
- Recruiting
Cabinet Medical
La Chaux-de-Fonds, 2300
NICOLE JOUAN, Site 015
- Recruiting
Cabinet Medical
La Chaux-de-Fonds, 2300
BENOIT BEN SAID, Site 016
- Recruiting
Cabinet Medical
La Chaux-de-Fonds, 2300
JOSIANE PARIER, Site 038
- Recruiting
Cabinet Medical
La Chaux-de-Fonds, 2300
MORAD LAHFA, Site 044
- Recruiting
Cabinet Medical
La Chaux-de-Fonds, 2300
ANNE CAROLINE COTTENCIN, Site 025
- Recruiting
Cabinet Medical
La Chaux-de-Fonds, 2300
MARC REVERTE, Site 029
- Recruiting
Cabinet Medical
La Chaux-de-Fonds, 2300
Mireille Ruer-Mulard, Site 007, +33442800590
- Completed
Local Institution - 056
La Chaux-de-Fonds, 2300
- Completed
Local Institution - 059
La Chaux-de-Fonds, 2300
About this study
Official title: 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
- Conditions
- Psoriasis
- Being tested
- Deucravacitinib
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
As prescribed by treating clinician
| Study group | Role | What they receive |
|---|---|---|
| Participants that have initiated deucravacitinib treatment | Not described Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment (PGA) 0/1 response
Measured: Baseline and at months 4, 12, 18 (optional), and 24
Dermatology Life Quality Index (DLQI) 0/1 response
Measured: Baseline and at months 4, 12, 18 (optional), and 24
Time from date of treatment initiation to date of discontinuation
Measured: Up to 24 months
Secondary outcomes (9)
Change in percentage involved Body Surface Area (BSA) from start of deucravacitinib treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and at months 4, 12, 18 (optional), and 24
Dermatology Life Quality Index (DLQI) score of ≤5
Measured: Baseline and at months 1, 4, 12 18 (optional) and 24
Body Surface Area (BSA) of ≤ 3%
Measured: Baseline and at months 4, 12, 18 (optional), and 24
Body Surface Area (BSA) of ≤ 1%
Measured: Baseline and at months 4, 12, 18 (optional), and 24
Reasons for deucravacitinib treatment discontinuation
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start29 Jan 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701513
- Sponsor's protocol ID
- IM011-1127
- Status last verified
- May 2026
- First submitted
- 20 Nov 2024
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No