Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Study Purpose

The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of 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:

  • - Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug.
  • - Self-identify as non-white or non-caucasian.
  • - Be a candidate for phototherapy or systemic treatment for psoriasis.
  • - Have an involved body surface area (BSA) greater than or equal to (>=) 10 percent (%), psoriasis area and severity index (PASI) >=12, investigator global assessment (IGA) >=3 at screening and at baseline (Cohort A), or have a scalp surface area >=30%, psoriasis scalp severity index (PSSI) >=12, scalp specific investigator global assessment (ss-IGA) >=3, and one plaque outside of the scalp at screening and at baseline (Cohort B) - Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention.
  • - Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention.

Exclusion Criteria:

  • - Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular) - Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug.
  • - Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
  • - Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients.
- Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening

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.

NCT05272150
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 3
Lead Sponsor

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

Janssen Research & Development, LLC
Principal Investigator

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

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

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

Industry
Overall Status Not yet recruiting
Countries United States
Conditions

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

Plaque Psoriasis, Scalp Psoriasis
Arms & Interventions

Arms

Experimental: Cohort A: Moderate-to-severe Plaque Psoriasis

Participants will receive either guselkumab subcutaneously (SC) or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Experimental: Cohort B: Moderate-to-severe Scalp Psoriasis

Participants will receive either guselkumab SC or placebo SC. Placebo participants will then crossover to receive guselkumab SC.

Interventions

Drug: - Guselkumab

Participants will receive guselkumab as subcutaneous injection.

Drug: - Placebo

Participants will receive placebo as subcutaneous injection.

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.

Skin Wellness Dermatology, Birmingham, Alabama

Status

Address

Skin Wellness Dermatology

Birmingham, Alabama, 35209

San Francisco, California

Status

Address

The Regents of the University of California

San Francisco, California, 94118

FXM Clinical Research Ft. Lauderdale, Fort Lauderdale, Florida

Status

Address

FXM Clinical Research Ft. Lauderdale

Fort Lauderdale, Florida, 33308

FXM Clinical Research Miramar, LLC, Miami, Florida

Status

Address

FXM Clinical Research Miramar, LLC

Miami, Florida, 33175

FXM Clinical Research Miramar, LLC, Miramar, Florida

Status

Address

FXM Clinical Research Miramar, LLC

Miramar, Florida, 33027

Water's Edge Dermatology Inc, Palm Beach Gardens, Florida

Status

Address

Water's Edge Dermatology Inc

Palm Beach Gardens, Florida, 33410

Marietta Dermatology Clinical Research, Marietta, Georgia

Status

Address

Marietta Dermatology Clinical Research

Marietta, Georgia, 30060

Boston University Medical Center, Boston, Massachusetts

Status

Address

Boston University Medical Center

Boston, Massachusetts, 02218

Dermatology Consulting Services, PLLC, High Point, North Carolina

Status

Address

Dermatology Consulting Services, PLLC

High Point, North Carolina, 27262

Cleveland, Ohio

Status

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Oregon Medical Research Center, Portland, Oregon

Status

Address

Oregon Medical Research Center

Portland, Oregon, 97223

Austin Institute for Clinical Research, Pflugerville, Texas

Status

Address

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

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