Psoriasis Clinical Trial
Official title:
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)
Verified date | March 2024 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, France, Germany, Poland, United Kingdom,
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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