A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion 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 [eg], erythrodermic, guttate, or pustular) - Has current drug-induced psoriasis (eg, 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 (eg, 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03451851
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Germany, Hungary, Italy, Netherlands, Poland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

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) and continue to receive guselkumab until drug approval for pediatric psoriasis or discontinuation of drug development. 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 of the study and continue to receive guselkumab until drug approval for pediatric psoriasis or discontinuation of drug development. 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 of the study and continue to receive guselkumab until drug approval for pediatric psoriasis or discontinuation of drug development. 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 until drug approval for pediatric psoriasis or discontinuation of drug development.

Interventions

Drug: - Guselkumab

Participants will receive a weight-based dose of guselkumab subcutaneously.

Drug: - Placebo for guselkumab

Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.

Drug: - Etanercept

Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Arizona, Tucson, Arizona

Status

Withdrawn

Address

University of Arizona

Tucson, Arizona, 85719

Stanford University, Palo Alto, California

Status

Recruiting

Address

Stanford University

Palo Alto, California, 94306

University of California, San Diego, San Diego, California

Status

Recruiting

Address

University of California, San Diego

San Diego, California, 92123

University of California, San Francisco, San Francisco, California

Status

Withdrawn

Address

University of California, San Francisco

San Francisco, California, 94115

Dermatologic Surgery Specialists, Macon, Georgia

Status

Completed

Address

Dermatologic Surgery Specialists

Macon, Georgia, 31217

Chicago, Illinois

Status

Recruiting

Address

Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital

Chicago, Illinois, 60611

Arlington Dermatology, Rolling Meadows, Illinois

Status

Recruiting

Address

Arlington Dermatology

Rolling Meadows, Illinois, 60008

Windsor Dermatology, East Windsor, New Jersey

Status

Recruiting

Address

Windsor Dermatology

East Windsor, New Jersey, 08520-2505

Mt. Sinai School of Medicine, New York, New York

Status

Recruiting

Address

Mt. Sinai School of Medicine

New York, New York, 10003

Arlington Center for Dermatology, Arlington, Texas

Status

Recruiting

Address

Arlington Center for Dermatology

Arlington, Texas, 76011-3800

Austin, Texas

Status

Recruiting

Address

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

International Sites

Eastern Health Research, Box Hill, Australia

Status

Completed

Address

Eastern Health Research

Box Hill, , 3128

Royal North Shore Hospital, St Leonards, Australia

Status

Completed

Address

Royal North Shore Hospital

St Leonards, , 2065

Veracity Clinical Research, Woolloongabba, Australia

Status

Completed

Address

Veracity Clinical Research

Woolloongabba, , 4102

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc

Brussels, , 1200

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Gent

Gent, , 9000

Liege, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liege, , 4000

Kirk Barber Reseach Inc., Calgary, Alberta, Canada

Status

Suspended

Address

Kirk Barber Reseach Inc.

Calgary, Alberta, T2G 1B1

Dermatology Research Institute Inc., Calgary, Alberta, Canada

Status

Suspended

Address

Dermatology Research Institute Inc.

Calgary, Alberta, T2J 7E1

Skin Care Centre, Vancouver, British Columbia, Canada

Status

Completed

Address

Skin Care Centre

Vancouver, British Columbia, V5Z 4E8

Eastern Canada Research Associates, Halifax, Nova Scotia, Canada

Status

Withdrawn

Address

Eastern Canada Research Associates

Halifax, Nova Scotia, B3H 1Z2

Berlin, Germany

Status

Withdrawn

Address

Charite - Universitatsmedizin Berlin (CCM)

Berlin, , 10117

ISA GmbH, Berlin, Germany

Status

Withdrawn

Address

ISA GmbH

Berlin, , 10789

Universitatsklinikum Bonn, Bonn, Germany

Status

Recruiting

Address

Universitatsklinikum Bonn

Bonn, , 53127

Dresden, Germany

Status

Recruiting

Address

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, , 01307

Universitatsklinikum Frankfurt, Frankfurt, Germany

Status

Recruiting

Address

Universitatsklinikum Frankfurt

Frankfurt, , 60590

Kiel, Germany

Status

Recruiting

Address

Universitatsklinikum Schleswig-Holstein - Kiel

Kiel, , 24105

Praxis Dr. med. Beate Schwarz - Germany, Langenau, Germany

Status

Recruiting

Address

Praxis Dr. med. Beate Schwarz - Germany

Langenau, , 89129

Universitaetsklinikum Muenster, Muenster, Germany

Status

Withdrawn

Address

Universitaetsklinikum Muenster

Muenster, , 48149

Selters, Germany

Status

Recruiting

Address

Company for Medical Study & Service Selters

Selters, , 56242

Hautarztpraxis Dr. Leitz & Kollegen, Stuttgart, Germany

Status

Recruiting

Address

Hautarztpraxis Dr. Leitz & Kollegen

Stuttgart, , 70178

Obudai Egeszsegugyi Centrum Kft., Budapest, Hungary

Status

Recruiting

Address

Obudai Egeszsegugyi Centrum Kft.

Budapest, , 1036

Debreceni Egyetem, Debrecen, Hungary

Status

Recruiting

Address

Debreceni Egyetem

Debrecen, , 4032

Miskolc, Hungary

Status

Recruiting

Address

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, , 3526

Szegedi Tudomanyegyetem, Szeged, Hungary

Status

Recruiting

Address

Szegedi Tudomanyegyetem

Szeged, , 6720

Medmare Egeszsegugyi Es Szolgaltato Bt., Veszprem, Hungary

Status

Withdrawn

Address

Medmare Egeszsegugyi Es Szolgaltato Bt.

Veszprem, , 8200

Ospedali Riuniti Di Ancona, Ancona, Italy

Status

Suspended

Address

Ospedali Riuniti Di Ancona

Ancona, , 60026

Bologna, Italy

Status

Suspended

Address

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

Bologna, , 40138

Ospedale San Raffaele, Milano, Italy

Status

Withdrawn

Address

Ospedale San Raffaele

Milano, , 20132

Azienda Ospedaliera di Padova, Padova, Italy

Status

Suspended

Address

Azienda Ospedaliera di Padova

Padova, , 35128

Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy

Status

Suspended

Address

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, , 42123

Radboud Umcn, Nijmegen, Netherlands

Status

Recruiting

Address

Radboud Umcn

Nijmegen, , 6525 GL

Dermed Centrum Medyczne Sp. z o.o, Lodz, Poland

Status

Suspended

Address

Dermed Centrum Medyczne Sp. z o.o

Lodz, , 90-265

Warszawa, Poland

Status

Suspended

Address

Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie

Warszawa, , 03-924

Wroclaw, Poland

Status

Suspended

Address

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , 50-368

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