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NCT Number: NCT05744466

A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis

The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis.

Recruiting

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Waltham, Massachusetts, 02451, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have been diagnosed with plaque psoriasis by a dermatologist
  • Newly initiating an eligible medication for enrollment (i.e., deucravacitinib, apremilast)
  • Actively enrolled in the CorEvitas Psoriasis Registry and have documented consent to allow copies of information from the registry be used for research purposes

Exclusion criteria

  • Participation (current or planned) in an interventional clinical trial (does not include observational registry or study)
  • Restart of treatments with the study eligible therapies previously received at any time during the participants' treatment history

Treatment and study plan

Deucravacitinib

Drug

As prescribed by treating clinician

Apremilast

Drug

As prescribed by treating clinician

Primary outcomes

  1. Change in body surface area (BSA)

    Time frame: At baseline and every 6 months up to 60 months or treatment discontinuation

  2. Investigator global assessment (IGA) response 0/1

    Time frame: Up to 60 months

  3. Dermatology life quality index (DLQI) response 0/1

    Time frame: Up to 60 months

  4. Time from date of treatment initiation to date of discontinuation

    Time frame: Up to 60 months

Secondary outcomes

  1. 75 percent improvement in Psoriasis area and severity index (PASI) score

    Time frame: At baseline and every 6 months up to 60 months or treatment discontinuation

  2. PASI score response ≤ 3

    Time frame: At baseline to follow-up, up to 60 months

  3. PASI score response ≤ 5

    Time frame: At baseline to follow-up, up to 60 months

  4. PASI score change from baseline

    Time frame: At baseline to follow-up, up to 60 months

  5. National psoriasis foundation (NPF) acceptable body surface area (BSA) response

    Time frame: At baseline to follow-up, up to 60 months

  6. NPF target BSA response

    Time frame: At baseline to follow-up, up to 60 months

  7. BSA ≤3%

    Time frame: At baseline to follow-up, up to 60 months

  8. Change in investigator global assessment (IGA) score

    Time frame: Up to 60 months

  9. Change in dermatology life quality index (DLQI) response

    Time frame: At baseline to follow-up, up to 60 months

  10. Change in DLQI response ≤5

    Time frame: At baseline to follow-up, up to 60 months

  11. Change in visual analog scale (VAS): Itch response

    Time frame: At baseline to follow-up, up to 60 months

  12. Change in VAS: Skin Pain response

    Time frame: At baseline to follow-up, up to 60 months

  13. Change in VAS: Fatigue Response

    Time frame: At baseline to follow-up, up to 60 months

  14. Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications

    Time frame: At baseline to follow-up, up to 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain the NCT# and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Real-world, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib Versus Apremilast in Adults With Plaque Psoriasis - North American Region

Acronym: RePhlect

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2023
Registry last updated
Jul 23, 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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