Recruiting

Deucravacitinib vs. Apremilast

Sponsor:

Bristol-Myers Squibb

Code:

NCT05744466

Conditions

Psoriasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Deucravacitinib

Apremilast

Study Details

Brief summary:

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

Conditions

Psoriasis

Study ID

NCT05744466

Start date

Sep 30, 2022

Status verified date

Jul, 2024

Completion date

Dec 10, 2027

Anticipated

Primary completion date

Dec 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Participants that have initiated deucravacitinib

Cohort 2

Participants that have initiated apremilast

Interventions

Deucravacitinib

As prescribed by treating clinician

Apremilast

As prescribed by treating clinician

Primary outcome measure

  • Change in body surface area (BSA) [ Time Frame: At baseline and every 6 months up to 60 months or treatment discontinuation ]
  • Investigator global assessment (IGA) response 0/1 [ Time Frame: Up to 60 months ]
  • Dermatology life quality index (DLQI) response 0/1 [ Time Frame: Up to 60 months ]
  • Time from date of treatment initiation to date of discontinuation [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286Clinical.Trials@bms.com

Locations

Local Institution

Recruiting

Waltham, Massachusetts, United States, 02451

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Keywords

  • Real-world
  • Deucravacitinib
  • Observational

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2024-07-23.