14
Participants
Start Date
February 20, 2018
Primary Completion Date
May 19, 2020
Study Completion Date
May 19, 2020
Emapalumab
Emapalumab was administered at an initial dose of 6 mg/kg by intravenous infusion. Emapalumab treatment continued at a dose of 3 mg/kg, every 3 days until study day 15, and then twice-a-week for an additional 2 weeks, i.e., until study day 28. The emapalumab regimen could be adapted (the frequency between infusions shortened, the dose increased, or the treatment prolonged beyond 4 weeks) upon assessment of a favourable benefit-risk profile. There was a 4-week off-drug follow-up period (up to Week 8).
Cincinnati Children'S Hospital, Cincinnati
Hôpital Necker-Enfants Malades, Unité d'Immunologie-hématologie et Rhumatologie pédiatriques, Paris
IRCCS Ospedale Pediatrico, Bambino Gesù, Rome
Hospital Sant Joan de Deu, Barcelona
Great Ormond Street Hospital for Children, London
Lead Sponsor
Swedish Orphan Biovitrum
INDUSTRY