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)

Who is this study for? Pediatric patients with chronic plaque psoriasis
Status: Active_not_recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Stanford University
Palo Alto
University of California, San Diego
San Diego
Georgia
Dermatologic Surgery Specialists
Macon
Illinois
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
Chicago
Arlington Dermatology
Rolling Meadows
New Jersey
Windsor Dermatology
East Windsor
New York
Mt. Sinai School of Medicine
New York
Ohio
Wright State Physicians Health Center
Dayton
Texas
Arlington Center for Dermatology
Arlington
Dell Children's Medical Center of Central Texas
Austin
Other Locations
Australia
Eastern Health Research
Box Hill
Royal North Shore Hospital
St Leonards
Veracity Clinical Research
Woolloongabba
Belgium
Cliniques Universitaires Saint Luc
Brussels
Universitair Ziekenhuis Gent
Ghent
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège
Canada
Dermatology Research Institute Inc
Calgary
Kirk Barber Reseach Inc.
Calgary
Skin Care Centre
Vancouver
Germany
Universitatsklinikum Bonn
Bonn
Universitatsklinikum Carl Gustav Carcus Dresden
Dresden
Universitatsklinikum Frankfurt
Frankfurt
Universitatsklinikum Schleswig Holstein Kiel
Kiel
Praxis Dr. med. Beate Schwarz - Germany
Langenau
Company for Medical Study & Service Selters
Selters
Hautarztpraxis Dr. Leitz & Kollegen
Stuttgart
Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest
Debreceni Egyetem
Debrecen
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
Miskolc
Szegedi Tudomanyegyetem
Szeged
Italy
Ospedali Riuniti Di Ancona
Ancona
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna
AOU di Cagliari
Cagliari
Azienda Ospedaliera di Padova
Padua
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia
Netherlands
Radboud University Medical Center
Nijmegen
Poland
Dermed Centrum Medyczne Sp z o o
Lodz
Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
Warsaw
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw
Time Frame
Start Date: 2018-07-11
Completion Date: 2026-12-18
Participants
Target number of participants: 120
Treatments
Experimental: Part 1 Group 1: Guselkumab
Participants in Part 1a (age greater than or equal to (\>=) 12 - less than (\<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose \>=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review.
Placebo_comparator: Part 1 Group 2: Placebo for Guselkumab
Participants in Part 1a (age \>= 12 - \<18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose \>=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review.
Active_comparator: Part 1 Group 3: Etanercept
Participants in Part 1a (age \>= 12 - \<18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review.
Experimental: Part 2: Guselkumab
Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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