Clinical trial NCT03451851: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Official title: A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis \[PsA\]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (\>=) 3, Psoriasis Area and Severity Index (PASI) \>=12, \>=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI\>=20, \>20% BSA involvement, or IGA=4
* Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment)
* Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy
* Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling
* Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention

Exclusion Criteria:

* Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)
* Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Has previously received guselkumab or etanercept
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (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
* Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly

Primary outcomes:
measure: Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: At Week 16
measure: Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16
timeFrame: At Week 16
measure: Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16
timeFrame: At Week 16
measure: Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16
timeFrame: At Week 16
measure: Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment
timeFrame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
measure: Part 1: Percentage of Retreated Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
timeFrame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
measure: Part 1: Percentage of Retreated Participants Who Achieved IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment
timeFrame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)
measure: Part 1: Cumulative Rate of Loss of at Least 50% of Week 16 PASI Improvement Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
timeFrame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Part 1: Cumulative Maintenance Rate of PASI 90 Response Through Week 52 Among Guselkumab PASI 90 Responders at Week 16
timeFrame: Week 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Part 1: Percentage of Participants Who Achieved a PASI 50 Response at Week 16
timeFrame: At Week 16
measure: Part 1: Percent Improvement From Baseline in PASI Through Week 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Part 2: Percent Improvement From Baseline in PASI Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
measure: Part 1: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Part 2: Percentage of Participants With PASI Responses (PASI 50, 75, 90, and 100) Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
measure: Part 1: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 16
timeFrame: Weeks 4, 8, 12, and 16
measure: Part 2: Percentage of Participants With IGA of Cleared (0), Cleared (0) or Minimal (1), Mild or Better (<=2) Through Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
measure: Part 2: Change From Baseline in CDLQI Score Through Week 52
timeFrame: Baseline, Weeks 8, 16, 28, 36, and 52
measure: Part 1: Percentage of Participants With CDLQI Score Equal to 0 or 1 at Week 16 Among Participants With a Baseline CDLQI Score Greater Than (>) 1
timeFrame: At Week 16
measure: Part 2: Percentage of Participants With CDLQI Score Equal to of 0 or 1 Through Week 52 Among Participants With a Baseline CDLQI Score > 1
timeFrame: Weeks 8, 16, 28, 36, and 52
measure: Part 1: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 at Week 16 Among Participants With a Baseline FDLQI >1
timeFrame: At Week 16
measure: Part 2: Percentage of Participants With Family Dermatology Life Quality Index (FDLQI) of 0 or 1 Through Week 52 Among Participants With a Baseline FDLQI >1
timeFrame: Weeks 8, 16, 28, 36, and 52
measure: Part 1: Change From Baseline in FDLQI Score at Week 16
timeFrame: Baseline and Week 16
measure: Part 2: Change From Baseline in FDLQI Score Through Week 52
timeFrame: Baseline, Weeks 8, 16, 28, 36, and 52
measure: Part 1: Change From Baseline in Body Surface Area (BSA) With Psoriasis Skin Involvement at Week 16
timeFrame: Baseline and Week 16
measure: Parts 2: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time Through Week 52
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52
measure: LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90, and 100) Over Time
timeFrame: From Week 52 to End of the study (EOS) (December 2026)
measure: LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] Over Time
timeFrame: From Week 52 to EOS (December 2026)
measure: LTE Phase: Percent Improvement From Baseline in PASI Over Time
timeFrame: From Week 52 to EOS (December 2026)
measure: LTE Phase: Change From Baseline in BSA With Psoriasis Skin Involvement Over Time
timeFrame: From Week 52 to EOS (Dec 2026)
measure: LTE Phase: Percentage of Participants Who Achieved PASI Responses (PASI 50, 75, 90,and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Participants Who Were Withdrawn From Guselkumab at Week 16 and Retreated Upon Loss of Response or at Week 52
timeFrame: Week 60 and Week 84
measure: LTE Phase: Percentage of Participants Who Achieved IGA Score of (Cleared [0], Cleared [0] or Minimal [1], Mild or Better [<=2] at Weeks 60 and 84 After Retreatment
timeFrame: Week 60 and Week 84
measure: LTE Phase: Percent Improvement in PASI Responses (PASI 50, 75, 90, and 100) at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52
timeFrame: Week 60 and Week 84
measure: LTE Phase: Change From Baseline in BSA at Weeks 60 and 84 After Retreatment Among Guselkumab Subjects Who Were Withdrawn From Guselkumab at Week 16 and Subsequently Retreated Upon Loss of Response or at Week 52
timeFrame: Week 60 and Week 84
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Macon
country: United States
facility: Dermatologic Surgery Specialists
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: East Windsor
country: United States
facility: Windsor Dermatology
state: New Jersey
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Dayton
country: United States
facility: Wright State Physicians Health Center
state: Ohio
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Box Hill
country: Australia
facility: Eastern Health Research
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
city: Calgary
country: Canada
facility: Kirk Barber Reseach Inc.
state: Alberta
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc
state: Alberta
city: Vancouver
country: Canada
facility: Skin Care Centre
state: British Columbia
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carcus Dresden
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig Holstein Kiel
city: Langenau
country: Germany
facility: Praxis Dr. med. Beate Schwarz - Germany
city: Selters
country: Germany
facility: Company for Medical Study & Service Selters
city: Stuttgart
country: Germany
facility: Hautarztpraxis Dr. Leitz & Kollegen
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Miskolc
country: Hungary
facility: Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Ancona
country: Italy
facility: Ospedali Riuniti Di Ancona
city: Bologna
country: Italy
facility: Azienda Ospedaliera Policlinico S. Orsola-Malpighi
city: Cagliari
country: Italy
facility: AOU di Cagliari
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - IRCCS
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne Sp z o o
city: Warszawa
country: Poland
facility: Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: