Overview
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-06-24
2024-06-24
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
BMS-986165
Criteria
Inclusion Criteria:1. 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
2. Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
3. Scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area
(SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at Screening visit and Day 1
4. ≥ 3% of Body Surface Area (BSA) involvement at Screening visit and Day 1
5. Evidence of plaque psoriasis in a non-scalp area
6. Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis
Exclusion Criteria:
- Target Disease Exceptions:
1. Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or
drug-induced psoriasis) at Screening or Day 1 Other protocol-defined
inclusion/exclusion criteria apply