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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID IM011-220  |   NCT05478499

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

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Summary

  • Phase 4
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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

Key Eligibility 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. 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Deucravacitinib

ASSIGNED INTERVENTION
  • Drug: Deucravacitinib

Study Arms

Placebo Comparator: Placebo then Deucravacitinib

ASSIGNED INTERVENTION
  • Drug: Deucravacitinib
  • Other: Placebo

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Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com