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NCT Number: NCT06382987

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

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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Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mebix. Inc., Minato-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Deucravacitinib

Drug

According to the product label

Apremilast

Drug

According to the product label

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up

    Time frame: 1 month, 3 months, 6 months and every 6 months up to 5 years

  14. Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Acronym: RePhlect

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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