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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05478499
Other study ID # IM011-220
Secondary ID 2022-000797-26U1
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 6, 2022
Est. completion date October 24, 2024

Study information

Verified date March 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 152
Est. completion date October 24, 2024
Est. primary completion date January 11, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Deucravacitinib
Specified dose on specified days
Other:
Placebo
Specified dose on specified days

Locations

Country Name City State
France Local Institution - 0019 Paris
France Local Institution - 0040 Romans sur Isere Cedex
France Local Institution - 0044 Rouen Cedex
Germany Local Institution - 0013 Frankfurt Hessen
Germany Local Institution - 0048 Hamburg
Germany Local Institution - 0012 Luebeck
Germany Local Institution - 0011 Mahlow
Germany Local Institution - 0038 Witten Deutschland
Poland Local Institution - 0026 Krakow
Poland Local Institution - 0017 Lodz
Poland Local Institution - 0014 Rzeszow
Poland Local Institution - 0015 Wroclaw
United Kingdom Local Institution - 0031 London Greater London
United Kingdom Local Institution - 0045 Salford Greater Manchester
United Kingdom Local Institution - 0039 Southampton Hampshire
United States Local Institution - 0008 Beverly Massachusetts
United States Local Institution - 0047 Bloomfield Hills Michigan
United States Local Institution - 0049 East Windsor New Jersey
United States Local Institution - 0002 Fridley Minnesota
United States Local Institution - 0001 Hot Springs Arkansas
United States Local Institution - 0033 Houston Texas
United States Local Institution - 0007 Indianapolis Indiana
United States Local Institution - 0051 Kew Gardens New York
United States Local Institution - 0041 Louisville Kentucky
United States Local Institution - 0006 Norfolk Virginia
United States Local Institution - 0005 Pittsburgh Pennsylvania
United States Local Institution - 0003 Portland Oregon
United States Local Institution - 0022 Rockville Maryland
United States Local Institution - 0004 San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Germany,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants Who Achieve Scalp-Specific Physician's Global Assessment (ss-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline At Week 16
Secondary Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90 At least 90% improvement from baseline in the PSSI score. At Week 16
Secondary Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score The Scalp Itch NRS is a participant administered, 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 in the past 24 hours. At Week 16
Secondary Proportion of Participants Who Achieve static Physician's Global Assessment (s-PGA) Score 0 (clear) or 1 (almost clear) with at least a 2-point Reduction from Baseline At Week 16
Secondary Number of Participants with Adverse Events (AEs) At Week 16
Secondary Number of Participants with Serious Adverse Events (SAEs) At Week 16
Secondary Number of Participants with Clinical Laboratory Abnormalities At Week 16
Secondary Number of Participants with Vital Sign Abnormalities At Week 16
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