41
Participants
Start Date
November 17, 2021
Primary Completion Date
July 4, 2025
Study Completion Date
May 19, 2029
Crovalimab
Crovalimab will be administered at a dose of 1000 mg intravenously (IV) (for participants weighing =\> 40 to \<100 kg) or 1500 mg IV (for participants weighing \>=100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, crovalimab will be administered at a dose of 340 mg subcutaneously (SC). On Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants weighing =\> 40 to \<100 kg) or 1020 mg SC (for participants weighing \>=100 kg). Enrollment of participants weighing \<40 kg will be staggered using two weight-based dose confirmation groups (Group 1 participants weighing \>=20 kg to \<40 kg, followed by Group 2 participants weighing \>=5 kg to \<20 kg). All participants will receive an initial IV loading dose, which will be followed by SC dosing at either Q2W or Q4W intervals (depending on body weight), until study completion.
UZ Leuven Gasthuisberg, Leuven
UZ Gent, Ghent
Hôpital Arnaud de Villeneuve, Montpellier
Hospital de Especialidades Puerta de Hierro S.A de C.V., Zapopan
Cincinnati Children's Hospital Medical Center, Cincinnati
University of Nebraska, Omaha
Gh Necker Enfants Malades, Paris
UT Health Science Center, San Antonio
Children's Hospital Colorado, Aurora
Peking University First Hospital, Beijing
Beijing Children's Hospital, Capital Medical University, Beijing
All India Institute Of Medical Sciences (AIIMS), New Delhi
Medanta-The Medicity, Gurgaon
The children's hospital , Zhejiang university school of medicine, Hangzhou
Institute of Kidney Diseases and Research Centre, Ahmedabad
Hackensack University Medical Center, Hackensack
Inst. Da Criança- Faculdade de Medicina Usp, São Paulo
CHU Sainte-Justine, Montreal
Aichi Children?s Health and Medical Center, Aichi
Chiba Children's Hospital, Chibashi, Chibaken
Uniwersyteckie Centrum Kliniczne, Gdansk
Instytut Centrum Zdrowia Matki Polki, Lodz
Collaborators (1)
Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY