A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Condition(s) studied
Investigational drug(s) / intervention(s)
Guselkumab: Participants will receive a weight-based dose of guselkumab subcutaneously.
Placebo for guselkumab: Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
Etanercept: Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
Study 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
Primary outcome measure(s)
- Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 — 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. - Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 — 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.
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Stanford University | Palo Alto | California | |
| University of California, San Diego | San Diego | California | |
| Dermatologic Surgery Specialists | Macon | Georgia | |
| Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital | Chicago | Illinois | |
| Arlington Dermatology | Rolling Meadows | Illinois | |
| Windsor Dermatology | East Windsor | New Jersey | |
| Mt. Sinai School of Medicine | New York | New York | |
| Wright State Physicians Health Center | Dayton | Ohio | |
| Arlington Center for Dermatology | Arlington | Texas | |
| Dell Children's Medical Center of Central Texas | Austin | Texas | |
| 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 | |
| Dermatology Research Institute Inc | Calgary | Alberta | |
| Skin Care Centre | Vancouver | British Columbia | |
| 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 | Padova | 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 |
More Janssen Research & Development, LLC trials in Poland
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03451851 on ClinicalTrials.gov ↗ ← All trials in Poland