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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 16

Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of a new drug, deucravacitinib, to placebo in people with moderate to severe scalp psoriasis.

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.Check my eligibility

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.See study design

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 below

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At least 3% of my body is affected by my condition.

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I have psoriasis plaques on parts of my body other than my scalp.

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I have tried at least one scalp psoriasis cream or ointment without success.

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I have severe scalp psoriasis covering more than 20% of my scalp.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change from Baseline in Scalp-specific Itch Numeric Rating Scale (NRS) Score

Number of Participants with Adverse Events (AEs)

Number of Participants with Clinical Laboratory Abnormalities

+4 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,362 Total Patients Enrolled

35 Trials studying Psoriasis

19,328 Patients Enrolled for Psoriasis

Media Library

Deucravacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05478499 — Phase 4

Psoriasis Research Study Groups: Deucravacitinib, Placebo then Deucravacitinib

Psoriasis Clinical Trial 2023: Deucravacitinib Highlights & Side Effects. Trial Name: NCT05478499 — Phase 4

Deucravacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478499 — Phase 4

Psoriasis Patient Testimony for trial: Trial Name: NCT05478499 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial taking place in a great number of Canadian hospitals?

"So far, 14 patients have enrolled at locations such as Skin Sciences, PLLC in Louisville and UPMC Department of Dermatology in Pittsburgh. Other enrollees are located at ALLCUTIS Research, LLC in Beverly and 14 other sites."

Answered by AI

Does Deucravacitinib have any severe short-term or long-term side effects?

"There is some evidence Deucravacitinib to be effective and it has undergone multiple rounds of testing, so it receives a 3 for safety."

Answered by AI

Who else is applying?

What state do they live in?

Florida

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

What site did they apply to?

Dermatology Clinical Research Center of San Antonio

Why did patients apply to this trial?

I have used several Rx's and they didnt work. I was in a trial with talconex and used it on scalp one month and symptoms subsided for three years. Can’t afford talconex nor the generic. Scalp psoriasis came back with a vengeance . Body psoriasis contained to two large areas, left side of abdomen and small of back area. Joints all ache because I have did, and gouty arthritis and fear I have psoriatic arthritis.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

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

2022. "Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05478499.

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