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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)
A Study of Efgartigimod IV in Participants From 12 Years to Less Than 18 Years of Age With Chronic Immune Thrombocytopenia (ITP)

NCT07194850

RecruitingPhase 2, Phase 3

Sponsor: argenx

Conditions: Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia, ITP, Immune Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura ( ITP )

Interventions: Efgartigimod IV, Placebo IV

Countries: France, Germany, Italy, Lithuania, Poland, Romania, Serbia, Spain

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

Eligibility overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Is aged 12 to less than 18 years when completing the informed consent process
* Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete
* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.
* Has documented prior response, defined as 1 platelet count of ≥50 × 10\^9/L to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin
* Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy
* Has documented mean platelet count of less than 30 x10\^9/L

Exclusion Criteria:

* Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP
* Nonimmune thrombocytopenia
* ITP-associated critical or severe bleeding
* History of hereditary thrombocytopenia
Locations (21)
  • Bordeaux, France
  • Berlin, Germany
  • Freiburg im Breisgau, Germany
  • Genoa, Italy
  • Monza, Italy
  • Roma, Italy
  • Torino, Italy
  • Vilnius, Lithuania
  • Lodz, Poland
  • Lublin, Poland
  • Bucharest, Romania
  • Belgrade, Serbia
  • Kragujevac, Serbia
  • Barcelona, Spain
  • Esplugues de Llobregat, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Cardiff, United Kingdom
  • Glasgow, United Kingdom
  • Manchester, United Kingdom