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

NCT03451851 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR108452CNTO1959PSO30112023-503378-19-00
• Study Type: interventional
• Target: 120
• Locations: 9 countries
• Sites: 39

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

Outcome Measures

Primary Outcomes (2)

• Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16

  The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

  At Week 16

• Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16

  The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.

  At Week 16

Secondary Outcomes (33)

• Part 1: Percentage of Participants Who Achieve PASI 90 Response at Week 16

  At Week 16

• Part 1: Percentage of Participants Who Achieved an IGA Score of Cleared (0) at Week 16

  At Week 16

• Part 1: Percentage of Participants Who Achieved PASI 100 Response at Week 16

  At Week 16

• Part 1: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 16

  Baseline and Week 16

• Part 1: Percentage of Retreated Participants Who Achieved a PASI 90 Response Over Time After Retreatment

  At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)

Study Arms (4)

Part 1 Group 1: Guselkumab

EXPERIMENTAL

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.

Drug: Guselkumab; Drug: Placebo for guselkumab

Part 1 Group 2: Placebo for Guselkumab

PLACEBO COMPARATOR

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.

Drug: Guselkumab; Drug: Placebo for guselkumab

Part 1 Group 3: Etanercept

ACTIVE COMPARATOR

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.

Drug: Guselkumab; Drug: Etanercept

Part 2: Guselkumab

EXPERIMENTAL

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.

Drug: Guselkumab

Interventions

Guselkumab DRUG

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

Also known as: CNTO1959

Part 1 Group 1: Guselkumab; Part 1 Group 2: Placebo for Guselkumab; Part 1 Group 3: Etanercept; Part 2: Guselkumab

Placebo for guselkumab DRUG

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

Part 1 Group 1: Guselkumab; Part 1 Group 2: Placebo for Guselkumab

Etanercept DRUG

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

Also known as: Enbrel

Part 1 Group 3: Etanercept

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (39)

Stanford University

Palo Alto, California, 94306, United States

Location

University of California, San Diego

San Diego, California, 92123, United States

Location

Dermatologic Surgery Specialists

Macon, Georgia, 31217, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Windsor Dermatology

East Windsor, New Jersey, 08520-2505, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10003, United States

Location

Wright State Physicians Health Center

Dayton, Ohio, 45324, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011-3800, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Eastern Health Research

Box Hill, 3128, Australia

Location

Royal North Shore Hospital

St Leonards, 2065, Australia

Location

Veracity Clinical Research

Woolloongabba, 4102, Australia

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

Location

Kirk Barber Reseach Inc.

Calgary, Alberta, T2G 1B1, Canada

Location

Dermatology Research Institute Inc

Calgary, Alberta, T2J 7E1, Canada

Location

Skin Care Centre

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105, Germany

Location

Praxis Dr. med. Beate Schwarz - Germany

Langenau, 89129, Germany

Location

Company for Medical Study & Service Selters

Selters, 56242, Germany

Location

Hautarztpraxis Dr. Leitz & Kollegen

Stuttgart, 70178, Germany

Location

Obudai Egeszsegugyi Centrum Kft

Budapest, 1036, Hungary

Location

Debreceni Egyetem

Debrecen, 4032, Hungary

Location

Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, 3526, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, 6720, Hungary

Location

Ospedali Riuniti Di Ancona

Ancona, 60026, Italy

Location

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

Bologna, 40138, Italy

Location

AOU di Cagliari

Cagliari, 09124, Italy

Location

Azienda Ospedaliera di Padova

Padova, 35128, Italy

Location

Arcispedale Santa Maria Nuova - IRCCS

Reggio Emilia, 42123, Italy

Location

Radboud University Medical Center

Nijmegen, 6525 GA, Netherlands

Location

Dermed Centrum Medyczne Sp z o o

Lodz, 90-265, Poland

Location

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

Warsaw, 03-924, Poland

Location

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, 50 556, Poland

Location

Related Publications (2)

• 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. 2026 Jan;28(1):69-81. doi: 10.1007/s40272-025-00725-2. Epub 2025 Oct 28.

  PMID: 41152645 DERIVED

• 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.

  PMID: 39708367 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab; Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: July 11, 2018
• Primary Completion: July 19, 2023
• Study Completion (Estimated): December 18, 2026
• Last Updated: April 13, 2026
• Results First Posted: March 28, 2025

Record last verified: 2026-04

Locations

CA (3); DE (7); AU (3); IT (5); BE (3); NL (1); PL (3); US (10); HU (4)