A Study to Evaluate the Effect of Deucravacitinib on Quality of Life in Participants With Plaque Psoriasis in a Community Setting

Phase 4

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Drug: Deucravacitinib; Other: Placebo

• Registration Number: NCT05701995
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-27
• Study Start: 2023-01-31
• Primary Completion: 2024-08-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Study Completion: 2025-05-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Target Disease Exceptions:

• Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1

Other protocol-defined inclusion/exclusion criteria apply.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo then Deucravacitinib	Placebo	-
Deucravacitinib	Deucravacitinib	-
Placebo then Deucravacitinib	Deucravacitinib	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants who achieve Dermatology Life Quality Index (DLQI) score 0 or 1	At week 16

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Between week 0 and week 16
Number of participants with clinical laboratory abnormalities	Between week 0 and week 16
Number of participants with a static Physician Global Assessment (s-PGA) score of 0 or 1 who had at least a 2-point reduction from baseline	At week 16
Proportion of participants who achieve a ≥4-point reduction from baseline in DLQI	At week 16
Change from baseline in whole-body itch Numerical Rating Scale (NRS) score at week 16	At week 16
Number of participants with serious adverse events (SAEs)	Between week 0 and week 16
Number of participants with vital sign abnormalities	Between week 0 and week 16

Trial Locations

Locations (38)

Local Institution - 0006; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0034; 🇺🇸 Scottsdale, Arizona, United States

Local Institution - 0015; 🇺🇸 North Little Rock, Arkansas, United States

Local Institution - 0004; 🇺🇸 Bakersfield, California, United States

Local Institution - 0009; 🇺🇸 Sacramento, California, United States

Local Institution - 0022; 🇺🇸 San Diego, California, United States

Local Institution - 0030; 🇺🇸 Centennial, Colorado, United States

Local Institution - 0024; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0027; 🇺🇸 Brandon, Florida, United States

Local Institution - 0016; 🇺🇸 Coral Gables, Florida, United States

Riverchase Dermatology; 🇺🇸 Pembroke Pines, Florida, United States

Local Institution - 0037; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0020; 🇺🇸 Snellville, Georgia, United States

Local Institution - 0007; 🇺🇸 Rolling Meadows, Illinois, United States

Local Institution - 0025; 🇺🇸 Skokie, Illinois, United States

Local Institution - 0036; 🇺🇸 Springfield, Illinois, United States

Local Institution - 0003; 🇺🇸 Baton Rouge, Louisiana, United States

Local Institution - 0018; 🇺🇸 Rockville, Maryland, United States

Local Institution - 0010; 🇺🇸 Auburn Hills, Michigan, United States

Local Institution - 0002; 🇺🇸 Waterford, Michigan, United States

Local Institution - 0017; 🇺🇸 Las Vegas, Nevada, United States

Local Institution - 0035; 🇺🇸 Reno, Nevada, United States

Local Institution - 0032; 🇺🇸 New York, New York, United States

Local Institution - 0013; 🇺🇸 New York, New York, United States

Local Institution - 0001; 🇺🇸 Rochester, New York, United States

Local Institution - 0005; 🇺🇸 Bexley, Ohio, United States

Local Institution - 0012; 🇺🇸 Mayfield Heights, Ohio, United States

Local Institution - 0019; 🇺🇸 Charleston, South Carolina, United States

Local Institution - 0029; 🇺🇸 Cypress, Texas, United States

Local Institution - 0028; 🇺🇸 Frisco, Texas, United States

Local Institution - 0008; 🇺🇸 South Jordan, Utah, United States

Local Institution - 0033; 🇺🇸 Springville, Utah, United States

Local Institution - 0021; 🇺🇸 Bellevue, Washington, United States

Local Institution - 0031; 🇺🇸 Mill Creek, Washington, United States

Local Institution - 0014; 🇺🇸 Spokane, Washington, United States

Local Institution - 0040; 🇵🇷 Caguas, Puerto Rico

Local Institution - 0038; 🇵🇷 Carolina, Puerto Rico

Local Institution - 0039; 🇵🇷 San Juan, Puerto Rico