A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Skin of Color Who Have Moderate-to-Severe Plaque Psoriasis and/or Moderate-to-Severe Scalp Psoriasis

Who is this study for? Patients with Psoriasis
What treatments are being studied? Guselkumab
Status: Completed
Location: See all (94) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Cahaba Research Inc
Birmingham
Total Skin and Beauty Dermatology Center
Birmingham
California
Stoll Dermatology
Beverly Hills
California Dermatology & Clinical Research Institute
Encinitas
First OC Dermatology
Fountain Valley
Center for Dermatology Clinical Research
Fremont
Community Regional Medical Center
Fresno
Paul Wallace MD
Ladera Heights
The Grimes Center for Medical and Aesthetic Dermatology
Los Angeles
Care Access Research
Newport Beach
MedDerm Associates
San Diego
Synergy Clinical Research
San Francisco
Southern California Dermatology
Santa Ana
Clinical Science Institute
Santa Monica
Connecticut
University of Connecticut Health Center
Farmington
Washington, D.c.
Center for Dermatology and Dermatologic Surgery
Washington D.c.
Florida
Skin Care Research
Boca Raton
Driven Research LLC
Coral Gables
Florida Academic Dermatology Centers
Coral Gables
Hollywood Dermatology and Cosmetic Surgery
Hollywood
International Dermatology Research, Inc.
Miami
Tory P Sullivan M D PA
North Miami Beach
Park Avenue Dermatology
Orange Park
Riverchase Dermatology and Cosmetic Surgery
Pembroke Pines
GCP Research
St. Petersburg
Forcare Clinical Research Inc
Tampa
Georgia
Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta
Advanced Medical Research
Atlanta
Skin Care Physicians of Georgia
Macon
Illinois
University Dermatology and Vein Clinic
Darien
Northshore University Healthsystem
Skokie
Dundee Dermatology
West Dundee
Indiana
Dawes Fretzin Clinical Research Group
Indianapolis
Indiana Clinical Trial Center
Plainfield
Kansas
Epiphany Dermatology of Kansas, LLC
Overland Park
Kentucky
Ds Research
Louisville
Massachusetts
Allcutis Research
Beverly
Metro Boston Clinical Partners
Brighton
Maryland
Callender Center for Clinical Research
Glenn Dale
Care Access Research
Marriottsville
DermAssociates, PC
Rockville
Lawrence J Green MD LLC
Rockville
Michigan
David Fivenson MD, Dermatology
Ann Arbor
St Joseph Dermatology and Vein Clinic
Saint Joseph
Somerset Skin Centre
Troy
Henry Ford Medical Center
West Bloomfield
Minnesota
Twin Cities Dermatology Center
Minneapolis
North Carolina
Accellacare Research of Cary
Cary
Darst Dermatology
Charlotte
Dermatology Specialists
Charlotte
Accellacare of Raleigh
Raleigh
PMG Research of Rocky Mount, LLC
Rocky Mount
PMG Research of Wilmington, LLC
Wilmington
Wake Forest Health Sciences
Winston-salem
Nebraska
Skin Specialists
Omaha
New Jersey
Psoriasis Treatment Center of Central New Jersey
East Windsor
Hudson Dermatology & Skin Cancer Center
Hoboken
Schweiger Dermatology Group
Verona
New York
Forest Hills Dermatology Group PLLC
Forest Hills
Markowitz Medical OptiSkin
New York
MDCS Dermatology
New York
Sadick Research Group
New York
Ohio
Advanced Dermatology and Skin Cancer Center
Boardman
Wright State Physicians Health Center
Dayton
Apex Dermatology Mayfield Heights
Mayfield Heights
Oklahoma
Central Sooner Research
Norman
Pennsylvania
Schweiger Dermatology Group
Exton
Temple University School of Medicine
Philadelphia
University of Pittsburgh Medical Center (UPMC)
Pittsburgh
South Carolina
Dermatology and Laser Center of Charleston
Charleston
Palmetto Clinical Trial Services, LLC
Fountain Inn
Texas
Arlington Center for Dermatology
Arlington
Dermatology Treatment & Research Center, PA
Dallas
Modern Research Associates PLLC
Dallas
Center for Clinical Studies
Houston
Suzanne Bruce and Associates - The Center for Skin Research
Houston
Austin Institute for Clinical Research
Pflugerville
Progressive Clinical Research
San Antonio
Texas Dermatology and Laser Specialists
San Antonio
Other Locations
Canada
CCA Medical Research Corporation
Ajax
Beacon Dermatology
Calgary
Dermatology Research Institute Inc
Calgary
Alberta DermaSurgery Centre
Edmonton
Dr Dusan Sajic Medicine Professional Corporation
Guelph
Lynderm Research Inc.
Markham
North York Research Inc
North York
JRB Research Inc
Ottawa
Nectar Research Group Inc
Richmond Hill
Dr. Chih ho Hong Medical
Surrey
Dr. Lorne E. Albrecht
Surrey
Canadian Dermatology Center
Toronto
FACET Dermatology
Toronto
Research Toronto
Toronto
Toronto Research Centre
Toronto
Time Frame
Start Date: 2022-07-13
Completion Date: 2025-05-30
Participants
Target number of participants: 213
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov