Recruiting NCT06382987
A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deucravacitinib, Apremilast.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Deucravacitinib
According to the product label - Drug Apremilast
According to the product label
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 2 centers
- Mebix. Inc. — Minato-ku
- Fukuoka University Hospital — Fukuoka
Identifiers
NCT: NCT06382987 · IM011-1124