Clinical trial NCT06382987: A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plaque Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib.
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation)
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Secondary outcomes:
measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
measure: Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up
timeFrame: 1 month, 3 months, 6 months and every 6 months up to 5 years
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Mebix. Inc.
state: Tokyo
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: