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Recruiting Observational

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

NCT06382987 · tracked via the Priya Life Science Japan tracker
Phase
Observational
Started
2024-01-22
Last updated
2024-04-25

Condition(s) studied

Plaque Psoriasis

Investigational drug(s) / intervention(s)

Deucravacitinib →Apremilast →

Deucravacitinib: According to the product label

Apremilast: According to the product label

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. — 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 — 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 — 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 — 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) — 1 month, 3 months, 6 months and every 6 months up to 5 years

Trial sites (2)

FacilityCityRegionStatus
Mebix. Inc. Minato-ku Tokyo Recruiting
Fukuoka University Hospital Fukuoka Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06382987 on ClinicalTrials.gov ↗ ← All trials in Japan