Clinical trial NCT05272150: Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Plaque Psoriasis
Scalp Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Cohort A: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response at Week 16
timeFrame: Week 16
measure: Cohort A: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
measure: Cohort B: Percentage of Participants who Achieve Psoriasis Scalp Severity Index (PSSI) 90 Response at Week 16
timeFrame: Week 16
measure: Cohort B: Percentage of Participants who Achieve Scalp-specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Cohort A: Percentage of Participants who Achieve IGA Score of Cleared (0) at Week 16
timeFrame: Week 16
measure: Cohort A: Percentage of Participants who Achieve PASI 100 Response at Week 16
timeFrame: Week 16
measure: Cohort A: Change from Baseline in PASI Score at Week 16
timeFrame: Baseline and Week 16
measure: Cohort A: Change from Baseline in Body Surface Area (BSA) at Week 16
timeFrame: Baseline and Week 16
measure: Cohort A: Time to >=90% Reduction in PASI Score
timeFrame: Up to Week 16
measure: Cohorts A and B: Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Cohort A: Percentage of Participants who Achieve >= 4-point Reduction (Improvement) from Baseline in the Psoriasis Symptom and Sign Diary (PSSD) Itch Score at Week 16, Among Participants with Baseline PSSD Itch >= 4 at Baseline
timeFrame: Week 16
measure: Cohorts A and B: Percentage of Participants who Achieve a PSSD Symptom Score of 0 at Week 16, Among Randomized Participants with Baseline PSSD Symptom Score >=1
timeFrame: Week 16
measure: Cohorts A and B: Change from Baseline in PSSD Symptom Score at Week 16
timeFrame: Baseline and Week 16
measure: Cohort B: Percentage of Participants who Achieve ss-IGA Score of Absence of Disease (0) at Week 16
timeFrame: Week 16
measure: Cohort B: Change from Baseline in Scalp Surface Area (SSA) at Week 16
timeFrame: Baseline and Week 16
measure: Cohort B: Percentage of Participants who Achieve PSSI 100 Response at Week 16
timeFrame: Week 16
measure: Cohort B: Change from Baseline in PSSI Score at Week 16
timeFrame: Baseline and Week 16
measure: Cohort B: Time to >=90% Reduction in PSSI Score
timeFrame: Up to Week 16
measure: Cohort B: Percentage of Participants with >= 4 Point Reduction (Improvement) from Baseline in the Scalp Itch NRS Score at Week 16, Among Participants with Baseline Scalp Itch >=4 at Baseline
timeFrame: Week 16
measure: Cohorts A and B: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Week 116
measure: Cohorts A and B: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 116
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research Inc
state: Alabama
city: Beverly Hills
country: United States
facility: Stoll Dermatology
state: California
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Ladera Heights
country: United States
facility: Paul Wallace MD
state: California
city: Los Angeles
country: United States
facility: The Grimes Center for Medical and Aesthetic Dermatology
state: California
city: Newport Beach
country: United States
facility: Care Access Research
state: California
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: San Francisco
country: United States
facility: Synergy Clinical Research
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Washington
country: United States
facility: Center for Dermatology and Dermatologic Surgery
state: District of Columbia
city: Boca Raton
country: United States
facility: Skin Care Research
state: Florida
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Hollywood
country: United States
facility: Hollywood Dermatology and Cosmetic Surgery
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: North Miami Beach
country: United States
facility: Tory P Sullivan M D PA
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Pembroke Pines
country: United States
facility: Riverchase Dermatology and Cosmetic Surgery
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research Inc
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Dermatology Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Advanced Medical Research
state: Georgia
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Darien
country: United States
facility: University Dermatology and Vein Clinic
state: Illinois
city: Skokie
country: United States
facility: Northshore University Healthsystem
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trial Center
state: Indiana
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas, LLC
state: Kansas
city: Louisville
country: United States
facility: Ds Research
state: Kentucky
city: Glenn Dale
country: United States
facility: Callender Center for Clinical Research
state: Maryland
city: Marriottsville
country: United States
facility: Care Access Research
state: Maryland
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Rockville
country: United States
facility: Lawrence J Green MD LLC
state: Maryland
city: Beverly
country: United States
facility: Allcutis Research
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson MD, Dermatology
state: Michigan
city: Saint Joseph
country: United States
facility: St Joseph Dermatology and Vein Clinic
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Twin Cities Dermatology Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists
state: Nebraska
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Hoboken
country: United States
facility: Hudson Dermatology & Skin Cancer Center
state: New Jersey
city: Verona
country: United States
facility: Schweiger Dermatology Group
state: New Jersey
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group PLLC
state: New York
city: New York
country: United States
facility: MDCS Dermatology
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: New York
country: United States
facility: Markowitz Medical OptiSkin
state: New York
city: Cary
country: United States
facility: Accellacare Research of Cary
state: North Carolina
city: Charlotte
country: United States
facility: Darst Dermatology
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology Specialists
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare of Raleigh
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
city: Boardman
country: United States
facility: Advanced Dermatology and Skin Cancer Center
state: Ohio
city: Dayton
country: United States
facility: Wright State Physicians Health Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Dermatology Mayfield Heights
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Exton
country: United States
facility: Schweiger Dermatology Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston
state: South Carolina
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center, PA
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates - The Center for Skin Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc
state: Alberta
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Alberta DermaSurgery Centre
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih ho Hong Medical
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Lorne E. Albrecht
state: British Columbia
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Guelph
country: Canada
facility: Dr Dusan Sajic Medicine Professional Corporation
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: North York
country: Canada
facility: North York Research Inc
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Inc
state: Ontario
city: Richmond Hill
country: Canada
facility: Nectar Research Group Inc
state: Ontario
city: Toronto
country: Canada
facility: Canadian Dermatology Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: