Plaque PsoriasisRePhlectNCT06382987
A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)
An observational study of Plaque Psoriasis, run by Bristol-Myers Squibb at 2 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Deucravacitinib and Apremilast
- How many people
- 600 participants
- Where
- 2 sitesJapan
- Study dates
- 22 Jan 2024to 31 Dec 2029
- How long will I take part?
- 5 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include Japanese adults with a physician-reported diagnosis of plaque psoriasis who start treated with either deucravacitinib or apremilast. Study participants will be enrolled from Japanese Dermatological Association (JDA)-certified hospitals and clinics that are allowed to prescribe molecular targeted agents for patients with psoriasis.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
Japan2 sites, 2 recruiting
- Recruiting
Fukuoka University Hospital
Fukuoka
- Recruiting
Mebix. Inc.
Minato-ku, Tokyo, 1070052
Minoru Tonogai, Site 0001
About this study
Official title: Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-World, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan
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.
- Conditions
- Plaque Psoriasis
- Being tested
- Deucravacitinib, Apremilast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
According to the product label
ApremilastDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Participants that have initiated deucravacitinib treatment | Not described Receives: Drug: Deucravacitinib | |
| Participants that have initiated apremilast treatment | Not described Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib.
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation)
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary outcomes (14)
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up
Measured: 1 month, 3 months, 6 months and every 6 months up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start22 Jan 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- 600 participants (estimated)
- Target duration
- 5 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
- NCT06382987
- Sponsor's protocol ID
- IM011-1124
- Acronym
- RePhlect
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- 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 25 Apr 2024. 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 Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan
- ClinicalTrials.gov ID
- NCT06382987
- Acronym / sponsor ID
- RePhlect / IM011-1124
- Conditions
- Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants that have initiated deucravacitinib treatment | – | Drug: Deucravacitinib |
| Participants that have initiated apremilast treatment | – | Drug: Apremilast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include Japanese adults with a physician-reported diagnosis of plaque psoriasis who start treated with either deucravacitinib or apremilast. Study participants will be enrolled from Japanese Dermatological Association (JDA)-certified hospitals and clinics that are allowed to prescribe molecular targeted agents for patients with psoriasis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| DeucravacitinibAccording to the product label | Drug | Participants that have initiated deucravacitinib treatment |
| ApremilastAccording to the product label | Drug | Participants that have initiated apremilast treatment |
Primary outcome
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib.
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation)
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
14 secondary outcomes
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up
Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years
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 25 Apr 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Bristol-Myers Squibb at 2 sites in Japan.
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 3 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 Study Connect Contact Center www.BMSStudyConnect.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?
Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. (time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years). The study lists 5 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 25 Apr 2024.