Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Psoriasis

Treatments: Other: Placebo; Drug: Deucravacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05478499

IM011-220

2022-000797-26 (EudraCT Number)

U1111-1274-7417 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. 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
4. ≥ 3% of Body Surface Area (BSA) involvement at the 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

Deucravacitinib

Experimental group

Treatment:

Drug: Deucravacitinib

Placebo then Deucravacitinib

Placebo Comparator group

Treatment:

Drug: Deucravacitinib

Other: Placebo