PsoriasisRePhlectNCT05744466
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
An observational study of Psoriasis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with 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 and Apremilast
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 10 Dec 2027
- 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: Adults diagnosed with moderate-to-severe plaque psoriasis who initiate deucravacitinib or apremilast within the CorEvitas Psoriasis Registry will be enrolled. Participants will be followed every 6 months from initiation up to 5 years or discontinuation, whichever occurs first. This is a real-world study and hence the follow-up are done based on the clinical practice done by dermatologists.
Who may be able to join
- Have been diagnosed with plaque psoriasis by a dermatologist
- Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast)
- Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes
Who cannot join
- Participation (current or planned) in an interventional clinical trial (does not include observational registry or study)
- Restart of treatments with the study eligible therapies previously received at any time during the participants' treatment history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain the NCT# and Site #. contact
United States1 site, 1 recruiting
- Recruiting
Local Institution
Waltham, Massachusetts, 02451
About this study
Official title: A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region
The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- Deucravacitinib, Apremilast
- Keywords
- Real-world, Deucravacitinib, Observational
- 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
ApremilastDrug
As prescribed by treating clinician
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants that have initiated deucravacitinib Receives: Drug: Deucravacitinib | |
| Cohort 2 | Participants that have initiated apremilast Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body surface area (BSA)
Measured: At baseline and every 6 months up to 60 months or treatment discontinuation
Investigator global assessment (IGA) response 0/1
Measured: Up to 60 months
Dermatology life quality index (DLQI) response 0/1
Measured: Up to 60 months
Time from date of treatment initiation to date of discontinuation
Measured: Up to 60 months
Secondary outcomes (14)
75 percent improvement in Psoriasis area and severity index (PASI) score
Measured: At baseline and every 6 months up to 60 months or treatment discontinuation
PASI score response ≤ 3
Measured: At baseline to follow-up, up to 60 months
PASI score response ≤ 5
Measured: At baseline to follow-up, up to 60 months
PASI score change from baseline
Measured: At baseline to follow-up, up to 60 months
National psoriasis foundation (NPF) acceptable body surface area (BSA) response
Measured: At baseline to follow-up, up to 60 months
NPF target BSA response
Measured: At baseline to follow-up, up to 60 months
BSA ≤3%
Measured: At baseline to follow-up, up to 60 months
Change in investigator global assessment (IGA) score
Measured: Up to 60 months
Change in dermatology life quality index (DLQI) response
Measured: At baseline to follow-up, up to 60 months
Change in DLQI response ≤5
Measured: At baseline to follow-up, up to 60 months
Change in visual analog scale (VAS): Itch response
Measured: At baseline to follow-up, up to 60 months
Change in VAS: Skin Pain response
Measured: At baseline to follow-up, up to 60 months
Change in VAS: Fatigue Response
Measured: At baseline to follow-up, up to 60 months
Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications
Measured: At baseline to follow-up, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start30 Sep 2022
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Dec 2027 (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
- 1,500 participants (estimated)
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
- NCT05744466
- Sponsor's protocol ID
- IM011-1105
- Acronym
- RePhlect
- Status last verified
- Jul 2024
- First submitted
- 30 Jan 2023
- Last updated
- 23 Jul 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region
- ClinicalTrials.gov ID
- NCT05744466
- Acronym / sponsor ID
- RePhlect / IM011-1105
- Conditions
- Psoriasis
- Keywords
- Real-world, Deucravacitinib, Observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 27 Feb 2023 (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 understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: DeucravacitinibParticipants that have initiated deucravacitinib |
| Cohort 2 | – | Drug: ApremilastParticipants that have initiated apremilast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with moderate-to-severe plaque psoriasis who initiate deucravacitinib or apremilast within the CorEvitas Psoriasis Registry will be enrolled. Participants will be followed every 6 months from initiation up to 5 years or discontinuation, whichever occurs first. This is a real-world study and hence the follow-up are done based on the clinical practice done by dermatologists.
Key inclusion criteria (3 listed)
- Have been diagnosed with plaque psoriasis by a dermatologist
- Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast)
- Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes
Key exclusion criteria (2 listed)
- Participation (current or planned) in an interventional clinical trial (does not include observational registry or study)
- Restart of treatments with the study eligible therapies previously received at any time during the participants' treatment history
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 | Cohort 1 |
| ApremilastAs prescribed by treating clinician | Drug | Cohort 2 |
Primary outcome
Change in body surface area (BSA)
Time frame: At baseline and every 6 months up to 60 months or treatment discontinuation
Investigator global assessment (IGA) response 0/1
Time frame: Up to 60 months
Dermatology life quality index (DLQI) response 0/1
Time frame: Up to 60 months
Time from date of treatment initiation to date of discontinuation
Time frame: Up to 60 months
14 secondary outcomes
75 percent improvement in Psoriasis area and severity index (PASI) score
Time frame: At baseline and every 6 months up to 60 months or treatment discontinuation
PASI score response ≤ 3
Time frame: At baseline to follow-up, up to 60 months
PASI score response ≤ 5
Time frame: At baseline to follow-up, up to 60 months
PASI score change from baseline
Time frame: At baseline to follow-up, up to 60 months
National psoriasis foundation (NPF) acceptable body surface area (BSA) response
Time frame: At baseline to follow-up, up to 60 months
NPF target BSA response
Time frame: At baseline to follow-up, up to 60 months
BSA ≤3%
Time frame: At baseline to follow-up, up to 60 months
Change in investigator global assessment (IGA) score
Time frame: Up to 60 months
Change in dermatology life quality index (DLQI) response
Time frame: At baseline to follow-up, up to 60 months
Change in DLQI response ≤5
Time frame: At baseline to follow-up, up to 60 months
Change in visual analog scale (VAS): Itch response
Time frame: At baseline to follow-up, up to 60 months
Change in VAS: Skin Pain response
Time frame: At baseline to follow-up, up to 60 months
Change in VAS: Fatigue Response
Time frame: At baseline to follow-up, up to 60 months
Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications
Time frame: At baseline to follow-up, up to 60 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 23 Jul 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 the NCT# and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: 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 1 site in United States.
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 3 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 body surface area (BSA) (time frame: At baseline and every 6 months up to 60 months or treatment discontinuation). The study lists 4 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 23 Jul 2024.