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A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)
Sponsor: argenx
Summary
The main purpose of this study is to confirm the correct dose of efgartigimod IV for treating patients aged 12 to younger than 18 years with chronic immune thrombocytopenia (ITP). The study consists of a double-blinded treatment period (DBTP) in which the participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV. At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first year open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second year (OLTP2). After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks. More information can be found here: https://clinicaltrials.argenx.com/advancejunior
Official title: A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-10-20
Completion Date
2030-10
Last Updated
2026-07-09
Healthy Volunteers
No
Conditions
Interventions
Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo IV
Intravenous infusion of placebo
Locations (20)
Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants
Bordeaux, France
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, Germany
Gaslini Children's Hospital
Genoa, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
Bambino Gesu Children's Hospital
Roma, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita
Torino, Italy
Vilnius University Hospital Santaros Klinikos, Children's Hospital
Vilnius, Lithuania
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny nr 4
Lodz, Poland
Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, Poland
Institutul Clinic Fundeni
Bucharest, Romania
Institute Of Mother And Child Healthcare Of Serbia Dr Vukan Cupic
Belgrade, Serbia
University Clinical Centre of Kragujevac
Kragujevac, Serbia
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, Spain
Hospital Infantil Universitario Nino Jesus (HIUNJS)
Madrid, Spain
Hospital Materno-Infantil Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Cardiff and Vale NHS Trust - University Hospital of Wales (UHW)
Cardiff, United Kingdom
The Royal Hospital for Children - Glasgow Health Board
Glasgow, United Kingdom
Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust
Manchester, United Kingdom