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Janus Kinase (JAK) Inhibitor
Deucravacitinib for Scalp Psoriasis
Phase 4
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
Evidence of plaque psoriasis in a non-scalp area
Must not have
Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is testing a medication called deucravacitinib to see if it can help people with moderate-to-severe scalp psoriasis. The medication works by blocking proteins that cause inflammation and immune responses, which are responsible for the red, itchy, and scaly patches on the scalp. The goal is to find out if this treatment is safe and effective.
Who is the study for?
This trial is for men and women with moderate-to-severe scalp psoriasis that's been stable for at least 6 months. Participants should be candidates for phototherapy or systemic therapy, have tried and not responded to one topical treatment, have a certain amount of scalp and body surface area affected, and can't have nonplaque forms of psoriasis.
What is being tested?
The study aims to see if Deucravacitinib is more effective and safe compared to a placebo in treating individuals with moderate-to-severe scalp psoriasis. It will involve giving some participants the actual drug while others receive an inactive substance (placebo) as a comparison.
What are the potential side effects?
While specific side effects are not listed here, common side effects from drugs like Deucravacitinib may include headache, nausea, diarrhea, high blood pressure, liver enzyme changes, respiratory infections among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
At least 3% of my body is affected by my condition.
Select...
I have psoriasis plaques on parts of my body other than my scalp.
Select...
I have tried at least one scalp psoriasis cream or ointment without success.
Select...
I have severe scalp psoriasis covering more than 20% of my scalp.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a type of psoriasis that is not plaque psoriasis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score
Proportion of Participants Who Achieve Psoriasis Scalp Severity Index (PSSI) Response 90
Side effects data
From 2023 Phase 2 trial • 67 Patients • NCT0487799025%
COVID-19
13%
Pneumonia
13%
Nasopharyngitis
8%
Cough
8%
Pyrexia
8%
Mouth ulceration
8%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Small intestinal obstruction
4%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
CROHN'S DISEASE
ULCERATIVE COLITIS
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DeucravacitinibExperimental Treatment1 Intervention
Group II: Placebo then DeucravacitinibPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deucravacitinib
2021
Completed Phase 4
~160
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Deucravacitinib is a selective TYK2 inhibitor that works by blocking the TYK2 enzyme, which plays a crucial role in the signaling pathways of inflammatory cytokines involved in psoriasis. This inhibition reduces the inflammatory response and helps control the symptoms of psoriasis.
Other common treatments include biologics, which target specific components of the immune system such as TNF-alpha, IL-17, and IL-23, and small molecule inhibitors like methotrexate and cyclosporine that broadly suppress the immune system. Understanding these mechanisms is important for psoriasis patients as it helps in selecting the most effective treatment with the least side effects, tailored to their specific condition and response to previous therapies.
Network meta-analyses for EGFR mutation-positive non-small-cell lung cancer: systematic review and overview of methods and shortcomings.Efficacy of treatment for acneiform eruptions related to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) for non-small cell lung cancer (NSCLC): A protocol of systematic review and network meta-analysis.Incidence of Skin Cancer in Patients With Chronic Inflammatory Cutaneous Diseases on Targeted Therapies: A Systematic Review and Meta-Analysis of Observational Studies.
Network meta-analyses for EGFR mutation-positive non-small-cell lung cancer: systematic review and overview of methods and shortcomings.Efficacy of treatment for acneiform eruptions related to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) for non-small cell lung cancer (NSCLC): A protocol of systematic review and network meta-analysis.Incidence of Skin Cancer in Patients With Chronic Inflammatory Cutaneous Diseases on Targeted Therapies: A Systematic Review and Meta-Analysis of Observational Studies.
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,124,751 Total Patients Enrolled
37 Trials studying Psoriasis
20,067 Patients Enrolled for Psoriasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- At least 3% of my body is affected by my condition.I have psoriasis plaques on parts of my body other than my scalp.I have tried at least one scalp psoriasis cream or ointment without success.I have had stable scalp psoriasis for at least 6 months.My doctor thinks I am a good candidate for light or systemic therapy.I have a type of psoriasis that is not plaque psoriasis.I have severe scalp psoriasis covering more than 20% of my scalp.
Research Study Groups:
This trial has the following groups:- Group 1: Deucravacitinib
- Group 2: Placebo then Deucravacitinib
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Psoriasis Patient Testimony for trial: Trial Name: NCT05478499 — Phase 4
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