Phase 4 N=180 Randomized Double-blind Treatment

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

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT05701995 ↗

Enrolled (actual)

180

Serious AEs

3.6%

Results posted

Sep 2025

Primary outcome: Primary: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 — 33.3; 6.7; 32.7; 6.1 Percentage of Participants — p=0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Deucravacitinib (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16	33.3; 6.7; 32.7; 6.1	0.0001 sig
SECONDARY Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	72.5; 53.3; 72.9; 53.1	0.0107 sig
SECONDARY Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16	-3.8; -1.8; -3.8; -1.8	<0.0001 sig
SECONDARY Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16	35.5; 8.2	0.0004 sig
SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16	63; 25	—
SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16	3; 1	—
SECONDARY Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16	1; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16	1; 0; 1; 0; 1; 0	—
SECONDARY Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16	0; 1; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16	0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1
Dermatology Life Quality Index (DLQI) score > 5 at the Screening Visit and Day 1
Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05701995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.