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

NCT06382987 — Recruiting, 600 participants, Bristol-Myers Squibb

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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

RegistryNCT06382987, acronym RePhlect
StatusRecruiting
Study typeObservational
Enrollment600 (Estimated)
SponsorBristol-Myers Squibb (Industry)
ConditionsPlaque Psoriasis
InterventionsDeucravacitinib, Apremilast (Drug)
Datesstart 2024-01-22, primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2024-04-25, last updated 2024-04-25
Locations2 sites in Japan

Related Papers Related Patents Related Grants Related Experts
All trials for Plaque Psoriasis All trials of Deucravacitinib All trials of Apremilast

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Participants that have initiated deucravacitinib treatmentDrug: Deucravacitinib
Participants that have initiated apremilast treatmentDrug: Apremilast
  • Deucravacitinib (Drug): According to the product label
  • Apremilast (Drug): According to the product label

+Outcome measures

Primary outcomes

  • 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]

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 [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) from baseline to follow-up [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [1 month, 3 months, 6 months and every 6 months up to 5 years]

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (2)

FacilityCityCountryStatus
Mebix. Inc.Minato-ku, TokyoJapanRecruiting
Fukuoka University HospitalFukuokaJapanRecruiting

+Investigators

  • Bristol-Myers Squibb, Study director, Bristol-Myers Squibb