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

NCT05744466 | Recruiting FDA Drug

• 1 other identifier: IM011-1105
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Keywords

Real-world; Deucravacitinib; Observational

Outcome Measures

Primary Outcomes (4)

• Change in body surface area (BSA)

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

• Investigator global assessment (IGA) response 0/1

  Up to 60 months

• Dermatology life quality index (DLQI) response 0/1

  Up to 60 months

• Time from date of treatment initiation to date of discontinuation

  Up to 60 months

Secondary Outcomes (14)

• 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

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

  At baseline to follow-up, up to 60 months

Study Arms (2)

Cohort 1

Participants that have initiated deucravacitinib

Drug: Deucravacitinib

Cohort 2

Participants that have initiated apremilast

Drug: Apremilast

Interventions

Deucravacitinib DRUG

As prescribed by treating clinician

Cohort 1

Apremilast DRUG

As prescribed by treating clinician

Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with moderate-to-severe plaque psoriasis who initiate deucravacitinib or apremilast within the CorEvitas Psoriasis Registry will be enrolled. Participants will be followed every 6 months from initiation up to 5 years or discontinuation, whichever occurs first. This is a real-world study and hence the follow-up are done based on the clinical practice done by dermatologists.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Waltham, Massachusetts, 02451, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib; apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

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

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

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 27, 2023
• Study Start: September 30, 2022
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)