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

A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Deucravacitinib; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Local Institution - 0019
  • Romans-sur-Isère, France, 26102
    • Local Institution - 0040
  • Rouen, France, 76031
    • Local Institution - 0044
• Germany
  • Hamburg, Germany, 20246
    • Local Institution - 0048
  • Lübeck, Germany, 23538
    • Local Institution - 0012
  • Mahlow, Germany, 15831
    • Local Institution - 0011
  • Deutschland
    • Witten, Deutschland, Germany, 58454
      • Local Institution - 0038
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Local Institution - 0013
• Poland
  • Krakow, Poland, 30438
    • Local Institution - 0026
  • Lodz, Poland, 90-436
    • Local Institution - 0017
  • Rzeszów, Poland, 35-055
    • Local Institution - 0014
  • Wroclaw, Poland, 51-685
    • Local Institution - 0015
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Local Institution - 0031
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Local Institution - 0045
  • HAMPSHIRE
    • Southampton, HAMPSHIRE, United Kingdom, SO16 6DU
      • Local Institution - 0039
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Local Institution - 0001
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Local Institution - 0007
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Local Institution - 0041
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Local Institution - 0022
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Local Institution - 0008
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Local Institution - 0047
  • Minnesota
    • New Brighton, Minnesota, United States, 55432
      • Local Institution - 0002
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Local Institution - 0049
  • New York
    • Kew Gardens, New York, United States, 11415
      • Local Institution - 0051
  • Oregon
    • Portland, Oregon, United States, 97201
      • Local Institution - 0003
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Local Institution - 0005
  • Texas
    • Houston, Texas, United States, 77004
      • Local Institution - 0033
    • San Antonio, Texas, United States, 78229
      • Local Institution - 0004
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Local Institution - 0006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165
Placebo Comparator: Placebo then Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165; Other: Placebo; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16	ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.	Baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16	PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms.	Baseline and Week 16
Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16	Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing "no scalp itch" and 10 representing "worst scalp itch imaginable.". Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours.	Baseline and Week 16
Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16	s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4).	Baseline and Week 16
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment.	From week 0 through week 16
Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)	A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.	From week 0 through week 16
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade	Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization.	Week 0 through Week 16
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests	Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal	Week 0 through Week 16
Number of Participants With Abnormalities in Vital Signs	Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.	Week 0 through Week 16

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Chair: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): October 17, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis; Deucravacitinib; BMS-986165; Scalp Psoriasis; Psoriasis Special Sites
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; deucravacitinib
• Other Study ID Numbers: IM011-220; 2022-000797-26 (EudraCT Number); U1111-1274-7417 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No