90
Participants
Start Date
March 9, 2022
Primary Completion Date
June 11, 2025
Study Completion Date
April 8, 2026
Crovalimab
Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 kg and 100 kg) or 1500 mg IV (for participants with body weight \>= 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 SC. For Week 5 and Q4W thereafter, crovalimab will be administered at a dose of 680 mg SC (for participants with body weight between 40 kg and 100 kg) or 1020 mg SC (for participants with body weight \>= 100 kg). Dosing schedule will be as per Arm Description.
Placebo
Matching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab.
Cukurova University Medical Faculty Balcali Hospital, Adana
Charlotte Maxeke Johannesburg Hospital, Johannesburg
Icahn School of Medicine at Mount Sinai, New York
East Carolina University, Greenville
Hospital General Univ. Gregorio Maranon, Madrid
International Cancer Institute (ICI), Eldoret
Mersin Universitesi Tip Fakultesi Hastanesi, Mersin
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi, Verona
Mississippi Center for Advanced Medicine, Madison
Hospital Universitario Virgen del Rocio, Seville
Children's Hospital of Michigan, Detroit
Hospital Universitario Miguel Servet, Zaragoza
CHU Henri Mondor, Créteil
Università degli Studi della Campania Luigi Vanvitelli, Napoli
Hospital Sao Rafael - HSR, Salvador
Hospital das Clinicas - UFRGS, Porto Alegre
Gertrude's Children Hospital, Nairobi
Hopital Nini, Tripoli
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu, Botucatu
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto, Ribeirão Preto
Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto
Beneficencia Portuguesa de Sao Paulo, São Paulo
HEMORIO, Rio de Janeiro
Hospital Samaritano, São Paulo
Amsterdam UMC Location VUMC, Amsterdam
Adana Acibadem Hospital; Pediatric Hematology, Adana
Central Middlesex Hospital, London
Hammersmith Hospital, London
Hoffmann-La Roche
INDUSTRY