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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06701513
- Acronym / sponsor ID
- IM011-1127
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants that have initiated deucravacitinib treatment | – | Drug: Deucravacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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
Key inclusion criteria (4 listed)
- ≥18 years of age
- Physician-reported diagnosis of moderate to severe plaque psoriasis
- Be newly initiating deucravacitinib
- Do not object to participate
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeucravacitinibAs prescribed by treating clinician | Drug | Participants that have initiated deucravacitinib treatment |
Primary outcome
Physician's Global Assessment (PGA) 0/1 response
Time frame: 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
Time from date of treatment initiation to date of discontinuation
Time frame: Up to 24 months
9 secondary outcomes
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
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
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
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
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
Dermatology Life Quality Index (DLQI) score of ≤5
Time frame: 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
Body Surface Area (BSA) of ≤ 1%
Time frame: Baseline and at months 4, 12, 18 (optional), and 24
Reasons for deucravacitinib treatment discontinuation
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Bristol-Myers Squibb at 48 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's Global Assessment (PGA) 0/1 response (time frame: Baseline and at months 4, 12, 18 (optional), and 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.