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

NCT ID: NCT03451851

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2026-12-18

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

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

Placebo for guselkumab

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Guselkumab

Intervention Type: DRUG

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

Placebo for guselkumab

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Guselkumab

Intervention Type: DRUG

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

Etanercept

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

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

Interventions

Guselkumab

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

Intervention Type: DRUG

Placebo for guselkumab

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

Intervention Type: DRUG

Etanercept

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

Intervention Type: DRUG

Other Intervention Names

CNTO1959; Enbrel

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Stanford University

Palo Alto, California, United States

University of California, San Diego

San Diego, California, United States

Dermatologic Surgery Specialists

Macon, Georgia, United States

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

Chicago, Illinois, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Windsor Dermatology

East Windsor, New Jersey, United States

Mt. Sinai School of Medicine

New York, New York, United States

Wright State Physicians Health Center

Dayton, Ohio, United States

Arlington Center for Dermatology

Arlington, Texas, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Eastern Health Research

Box Hill, , Australia

Royal North Shore Hospital

St Leonards, , Australia

Veracity Clinical Research

Woolloongabba, , Australia

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, , Belgium

Kirk Barber Reseach Inc.

Calgary, Alberta, Canada

Dermatology Research Institute Inc

Calgary, Alberta, Canada

Skin Care Centre

Vancouver, British Columbia, Canada

Universitatsklinikum Bonn

Bonn, , Germany

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, , Germany

Universitatsklinikum Frankfurt

Frankfurt, , Germany

Universitatsklinikum Schleswig Holstein Kiel

Kiel, , Germany

Praxis Dr. med. Beate Schwarz - Germany

Langenau, , Germany

Company for Medical Study & Service Selters

Selters, , Germany

Hautarztpraxis Dr. Leitz & Kollegen

Stuttgart, , Germany

Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

Debreceni Egyetem

Debrecen, , Hungary

Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, , Hungary

Szegedi Tudomanyegyetem

Szeged, , Hungary

Ospedali Riuniti Di Ancona

Ancona, , Italy

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

Bologna, , Italy

AOU di Cagliari

Cagliari, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, , Italy

Radboud University Medical Center

Nijmegen, , Netherlands

Dermed Centrum Medyczne Sp z o o

Lodz, , Poland

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

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, , Poland

Countries

Brazil; Russia; United States; Australia; Belgium; Canada; Germany; Hungary; Italy; Netherlands; Poland

References

Crauwels H, Ringold S, Howard S, Van Hartingsveldt B, Smith V, Jett M, Baguet T, Adamson E, Chakravarty SD, Leu JH. Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data. Paediatr Drugs. 2025 Oct 28. doi: 10.1007/s40272-025-00725-2. Online ahead of print.

Reference Type: DERIVED

PMID: 41152645 (View on PubMed)

Prajapati VH, Seyger MMB, Wilsmann-Theis D, Szakos E, Kaszuba A, van Hartingsveldt B, Jett M, Jiang G, Li S, Sinha V, Crauwels H, DeKlotz CMC, Paller AS. Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study. Br J Dermatol. 2025 Mar 18;192(4):618-628. doi: 10.1093/bjd/ljae502.

Reference Type: DERIVED

PMID: 39708367 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTO1959PSO3011

Identifier Type: OTHER

Identifier Source: secondary_id

2023-503378-19-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108452

Identifier Type: -

Identifier Source: org_study_id