Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis
- Registration Number
- NCT05478499
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Deucravacitinib Deucravacitinib - Placebo then Deucravacitinib Placebo - Placebo then Deucravacitinib Deucravacitinib -
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 Baseline and 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 Baseline and 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.
Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 Baseline and 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.
Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 Baseline and 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).
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) From week 0 through week 16 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.
Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) From week 0 through week 16 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.
Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade Week 0 through Week 16 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.
Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests Week 0 through Week 16 Number of participants with laboratory abnormalities in potential drug-induced liver injury tests.
ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normalNumber of Participants With Abnormalities in Vital Signs Week 0 through Week 16 Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.
Trial Locations
- Locations (29)
Local Institution - 0001
🇺🇸Hot Springs, Arkansas, United States
Local Institution - 0007
🇺🇸Indianapolis, Indiana, United States
Local Institution - 0041
🇺🇸Louisville, Kentucky, United States
Local Institution - 0022
🇺🇸Rockville, Maryland, United States
Local Institution - 0008
🇺🇸Beverly, Massachusetts, United States
Local Institution - 0047
🇺🇸Bloomfield Hills, Michigan, United States
Local Institution - 0002
🇺🇸New Brighton, Minnesota, United States
Local Institution - 0049
🇺🇸East Windsor, New Jersey, United States
Local Institution - 0051
🇺🇸Kew Gardens, New York, United States
Local Institution - 0003
🇺🇸Portland, Oregon, United States
Local Institution - 0005
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0033
🇺🇸Houston, Texas, United States
Local Institution - 0004
🇺🇸San Antonio, Texas, United States
Local Institution - 0006
🇺🇸Norfolk, Virginia, United States
Local Institution - 0019
🇫🇷Paris, France
Local Institution - 0040
🇫🇷Romans sur Isere Cedex, France
Local Institution - 0044
🇫🇷Rouen Cedex, France
Local Institution - 0038
🇩🇪Witten, Deutschland, Germany
Local Institution - 0013
🇩🇪Frankfurt, Hessen, Germany
Local Institution - 0048
🇩🇪Hamburg, Germany
Local Institution - 0012
🇩🇪Luebeck, Germany
Local Institution - 0011
🇩🇪Mahlow, Germany
Local Institution - 0026
🇵🇱Krakow, Poland
Local Institution - 0017
🇵🇱Lodz, Poland
Local Institution - 0014
🇵🇱Rzeszow, Poland
Local Institution - 0015
🇵🇱Wroclaw, Poland
Local Institution - 0031
🇬🇧London, Greater London, United Kingdom
Local Institution - 0045
🇬🇧Salford, Greater Manchester, United Kingdom
Local Institution - 0039
🇬🇧Southampton, Hampshire, United Kingdom