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

Recruiting

• Conditions: Psoriasis
• Interventions: Drug: Apremilast; Drug: Deucravacitinib

• Registration Number: NCT05744466
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2027-12-10
• Study Completion: 2027-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	Apremilast	Participants that have initiated apremilast
Cohort 1	Deucravacitinib	Participants that have initiated deucravacitinib

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in dermatology life quality index (DLQI) response	At baseline to follow-up, up to 60 months
National psoriasis foundation (NPF) acceptable body surface area (BSA) response	At baseline to follow-up, up to 60 months
Merit-based Incentive Payment System (MIPS) Clinical Response to Oral Systemic or Biologic Medications	At baseline to follow-up, up to 60 months
NPF target BSA response	At baseline to follow-up, up to 60 months
75 percent improvement in Psoriasis area and severity index (PASI) score	At baseline and every 6 months up to 60 months or treatment discontinuation
PASI score response ≤ 3	At baseline to follow-up, up to 60 months
PASI score response ≤ 5	At baseline to follow-up, up to 60 months
PASI score change from baseline	At baseline to follow-up, up to 60 months
Change in investigator global assessment (IGA) score	Up to 60 months
Change in VAS: Fatigue Response	At baseline to follow-up, up to 60 months
BSA ≤3%	At baseline to follow-up, up to 60 months
Change in VAS: Skin Pain response	At baseline to follow-up, up to 60 months
Change in DLQI response ≤5	At baseline to follow-up, up to 60 months
Change in visual analog scale (VAS): Itch response	At baseline to follow-up, up to 60 months

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Waltham, Massachusetts, United States