Clinical trial NCT06039189: Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
Official title: A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate Plaque Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 338
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 compared to an inactive drug in participants with low body surface area moderate plaque psoriasis and special site involvement.


Eligibility criteria: Inclusion Criteria:

* All participants must have a diagnosis of plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before first administration of study intervention
* All participants must meet the following disease severity criteria at screening and at baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside of special sites; (c) Involvement of at least 1 special site with at least moderate severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal to (\>=) 3, face with facial psoriasis IGA \>=3, intertriginous with intertriginous psoriasis IGA \>=3, or genital with static physician global assessment of genitalia (sPGA-G) \>=3
* All participants be inadequately controlled with or intolerant of at least 1 prior topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D, or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus, anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the treatment of psoriasis at both screening
* All participants be a candidate for phototherapy or systemic treatment for psoriasis

Exclusion Criteria:

* Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at screening or randomization
* Has current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* For participants with palmoplantar involvement, confounding diagnoses, including, but not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded
* Participants will not be eligible if they have ever received prior biologic (or biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any other indications that could impact the assessment of psoriasis. Prior biologics (or biosimilars of) may include, but not limited to, tumor necrosis factor (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab, brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)
* Has a history of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (for example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Primary outcomes:
measure: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) at Week 16
timeFrame: Week 16
measure: Percentage of Participants who Achieve a PASI 90 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants who Achieve a PASI 100 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score >=3 at Baseline
timeFrame: Week 16
measure: Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score >=3 at Baseline
timeFrame: Week 16
measure: Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score >=3 at Baseline
timeFrame: Week 16
measure: Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score >=3 at Baseline
timeFrame: Week 16
measure: Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16
timeFrame: Baseline, Week 16
measure: Percentage of Participants who Achieve >=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline
timeFrame: Week 16
measure: Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD >0 at Baseline
timeFrame: Week 16
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Week 56
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to Week 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Dermatology
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research Inc
state: Alabama
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: Riverside
country: United States
facility: Practice Wang
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Ana
country: United States
facility: Rehlen, Bartlow, Goodman and Baron Dermatology Group
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Farmington
country: United States
facility: University of Conn Health Center
state: Connecticut
city: Brandon
country: United States
facility: TrueBlue Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Doral
country: United States
facility: Revival Research
state: Florida
city: Margate
country: United States
facility: Glick Research Institute
state: Florida
city: Miami
country: United States
facility: Miami VA Healthcare System
state: Florida
city: North Miami Beach
country: United States
facility: Tory P Sullivan M D PA
state: Florida
city: Atlanta
country: United States
facility: Atlanta Biomedical Clinical Research
state: Georgia
city: Columbia
country: United States
facility: Kindred Hair and Skin Center
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: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Quincy
country: United States
facility: DermCare, LLC
state: Massachusetts
city: West Bloomfield
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
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: Huntersville
country: United States
facility: Piedmont Plastic Surgery and Dermatology
state: North Carolina
city: Bexley
country: United States
facility: Bexley dermatology research
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Dermatology Mayfield Heights
state: Ohio
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: Nashville
country: United States
facility: Nashville Skin: Comprehensive Dermatology Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Bellaire
country: United States
facility: Bellair Dermatology
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Dallas
country: United States
facility: Bare Dermatology
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
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: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology
state: Texas
city: Mill Creek
country: United States
facility: Frontier Derm Partners CRO, LLC
state: Washington
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology Clinic Edmonton Downtown
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih ho Hong Medical
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Fredericton
country: Canada
facility: Brunswick Dermatology Center
state: New Brunswick
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: London
country: Canada
facility: Dr Wei Jing Loo Medicine Professional Corporation
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: 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
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Quebec
country: Canada
facility: The Centre de recherche Saint-Louis
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: