Phase 4
N=154
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT05478499 ↗Enrolled (actual)
154
Serious AEs
2.1%
Results posted
Mar 2025
Primary outcome: Primary: Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 — 48.5; 13.7; 50.0; 12.8 Percentage of responders — 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
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 |
48.5; 13.7; 50.0; 12.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 |
38.8; 2.0; 40.6; 2.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 |
-3.2; -0.7; -3.3; -0.9 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 |
51.0; 4.3 | <0.0001 sig |
| SECONDARY Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
73; 26 | — |
| SECONDARY Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) |
1; 1 | — |
| SECONDARY Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade |
0; 0; 4; 2; 0; 0 | — |
| SECONDARY Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormalities in Vital Signs |
0; 0; 1; 3; 0; 0 | — |
Summary
The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.
Eligibility Criteria
Inclusion Criteria
- Men and women diagnosed with stable plaque psoriasis with scalp involvement 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
- Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1
- ≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
- Evidence of plaque psoriasis in a non-scalp area
- Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis
Exclusion Criteria
- Target Disease Exceptions:
- Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1 Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT05478499). 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.