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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05478499
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Germany, Poland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Deucravacitinib

Placebo Comparator: Placebo then Deucravacitinib

Interventions

Drug: - Deucravacitinib

Specified dose on specified days

Other: - Placebo

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Burke Pharmaceutical Research, Hot Springs, Arkansas

Status

Recruiting

Address

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913

Site Contact

Dowling Stough, Site 0001

Clinical.Trials@bms.com

501-620-4449

Los Angeles, California

Status

Withdrawn

Address

Keck School of Medicine of University of Southern California

Los Angeles, California, 90033

Indianapolis, Indiana

Status

Withdrawn

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256

Site Contact

Scott Fretzin, Site 0007

Clinical.Trials@bms.com

317-516-5030

Skin Sciences, PLLC, Louisville, Kentucky

Status

Recruiting

Address

Skin Sciences, PLLC

Louisville, Kentucky, 40217

Site Contact

Leon Kircik, Site 0041

Clinical.Trials@bms.com

502-451-9000

Lawrence J. Green, MD. LLC, Rockville, Maryland

Status

Recruiting

Address

Lawrence J. Green, MD. LLC

Rockville, Maryland, 20850

Site Contact

Lawrence Green, Site 0022

Clinical.Trials@bms.com

301-610-0663

ALLCUTIS Research, LLC, Beverly, Massachusetts

Status

Recruiting

Address

ALLCUTIS Research, LLC

Beverly, Massachusetts, 01915

Site Contact

David Greenstein, Site 0008

Clinical.Trials@bms.com

978-969-6897

Henry Ford Medical Center -, Bloomfield Hills, Michigan

Status

Recruiting

Address

Henry Ford Medical Center -

Bloomfield Hills, Michigan, 48302

Site Contact

Linda Stein Gold, Site 0047

Clinical.Trials@bms.com

248-884-5356

Minnesota Clinical Study Center, Fridley, Minnesota

Status

Recruiting

Address

Minnesota Clinical Study Center

Fridley, Minnesota, 55432

Site Contact

Steven Kempers, Site 0002

Clinical.Trials@bms.com

763-571-4200

Psoriasis Treatment Center of Central NJ, East Windsor, New Jersey

Status

Recruiting

Address

Psoriasis Treatment Center of Central NJ

East Windsor, New Jersey, 08520

Site Contact

Jerry Bagel, Site 0049

Clinical.Trials@bms.com

160944345004434500

Forest Hill Dermatology Group, Kew Gardens, New York

Status

Recruiting

Address

Forest Hill Dermatology Group

Kew Gardens, New York, 11415

Site Contact

Jeffrey Weinberg, Site 0051

Clinical.Trials@bms.com

212-523-3808

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Withdrawn

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Oregon Medical Research Center, Portland, Oregon

Status

Recruiting

Address

Oregon Medical Research Center

Portland, Oregon, 97223-6683

Site Contact

Andrew Blauvelt, Site 0003

Clinical.Trials@bms.com

503-245-1525

UPMC Department of Dermatology, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Department of Dermatology

Pittsburgh, Pennsylvania, 15213

Site Contact

Timothy Patton, Site 0005

Clinical.Trials@bms.com

412-647-2013

Center for Clinical Studies, Houston, Texas

Status

Withdrawn

Address

Center for Clinical Studies

Houston, Texas, 77004

Center for Clinical Studies, Houston, Texas

Status

Recruiting

Address

Center for Clinical Studies

Houston, Texas, 77004

Site Contact

Stephen Tyring, Site 0033

Clinical.Trials@bms.com

713-528-8818

San Antonio, Texas

Status

Recruiting

Address

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229

Site Contact

Steven Davis, Site 0004

Clinical.Trials@bms.com

210-614-0530

University of Utah MidValley Dermatology, Murray, Utah

Status

Withdrawn

Address

University of Utah MidValley Dermatology

Murray, Utah, 84107

Virginia Clinical Research , Inc, Norfolk, Virginia

Status

Recruiting

Address

Virginia Clinical Research , Inc

Norfolk, Virginia, 23502

Site Contact

David Pariser, Site 0006

Clinical.Trials@bms.com

757-625-0151

International Sites

Local Institution - 0019, Paris, France

Status

Recruiting

Address

Local Institution - 0019

Paris, , 75010

Site Contact

Site 0019

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0040, Romans sur Isere Cedex, France

Status

Recruiting

Address

Local Institution - 0040

Romans sur Isere Cedex, , 26102

Site Contact

Site 0040

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0044, Rouen, France

Status

Recruiting

Address

Local Institution - 0044

Rouen, , 76031

Site Contact

Site 0044

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0035, Mahlow, Brandenburg, Germany

Status

Withdrawn

Address

Local Institution - 0035

Mahlow, Brandenburg, 15831

Local Institution - 0038, Witten, Deutschland, Germany

Status

Recruiting

Address

Local Institution - 0038

Witten, Deutschland, 58454

Site Contact

Site 0038

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0013, Frankfurt, Hessen, Germany

Status

Recruiting

Address

Local Institution - 0013

Frankfurt, Hessen, 60590

Site Contact

Site 0013

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0050, Luebeck, Schleswig-Holstein, Germany

Status

Withdrawn

Address

Local Institution - 0050

Luebeck, Schleswig-Holstein, 23538

Local Institution - 0048, Hamburg, Germany

Status

Recruiting

Address

Local Institution - 0048

Hamburg, , 20246

Site Contact

Site 0048

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0012, Luebeck, Germany

Status

Recruiting

Address

Local Institution - 0012

Luebeck, , 23538

Site Contact

Site 0012

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0011, Mahlow, Germany

Status

Recruiting

Address

Local Institution - 0011

Mahlow, , 15831

Site Contact

Site 0011

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0037, Lodz, Woj.Lodzkie, Poland

Status

Withdrawn

Address

Local Institution - 0037

Lodz, Woj.Lodzkie, 90-436

Local Institution - 0046, Lodz, Woj.Lodzkie, Poland

Status

Withdrawn

Address

Local Institution - 0046

Lodz, Woj.Lodzkie, 90-436

Local Institution - 0026, Krakow, Poland

Status

Recruiting

Address

Local Institution - 0026

Krakow, , 30438

Site Contact

Site 0026

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0017, Lodz, Poland

Status

Recruiting

Address

Local Institution - 0017

Lodz, , 90-436

Site Contact

Site 0017

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0014, Rzeszow, Poland

Status

Recruiting

Address

Local Institution - 0014

Rzeszow, , 35-001

Site Contact

Site 0014

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0027, Rzeszow, Poland

Status

Withdrawn

Address

Local Institution - 0027

Rzeszow, , 35-001

Local Institution - 0015, Wroclaw, Poland

Status

Recruiting

Address

Local Institution - 0015

Wroclaw, , 51-685

Site Contact

Site 0015

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0036, Wroclaw, Poland

Status

Withdrawn

Address

Local Institution - 0036

Wroclaw, , 51-685

Local Institution - 0031, London, Greater London, United Kingdom

Status

Recruiting

Address

Local Institution - 0031

London, Greater London, SE1 9RT

Site Contact

Site 0031

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0045, Salford, Greater Manchester, United Kingdom

Status

Recruiting

Address

Local Institution - 0045

Salford, Greater Manchester, M6 8HD

Site Contact

Site 0045

Clinical.Trials@bms.com

855-907-3286

Local Institution - 0039, Southampton, Hampshire, United Kingdom

Status

Recruiting

Address

Local Institution - 0039

Southampton, Hampshire, SO16 6DU

Site Contact

Site 0039

Clinical.Trials@bms.com

855-907-3286

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.