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A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
Sponsor: Hoffmann-La Roche
Summary
This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.
Official title: A Randomized Double-Blind Phase IIA Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)
Key Details
Gender
All
Age Range
12 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2022-03-09
Completion Date
2026-03-31
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (27)
Children's Hospital of Michigan
Detroit, Michigan, United States
Mississippi Center for Advanced Medicine
Madison, Mississippi, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
East Carolina University
Greenville, North Carolina, United States
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, Brazil
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo, Brazil
HEMORIO
Rio de Janeiro, Brazil
Hospital Samaritano
São Paulo, Brazil
CHU Henri Mondor
Créteil, France
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi
Verona, Veneto, Italy
International Cancer Institute (ICI)
Eldoret, Kenya
Gertrude's Children Hospital
Nairobi, Kenya
Hopital Nini
Tripoli, Lebanon
Amsterdam UMC Location VUMC
Amsterdam, Netherlands
Charlotte Maxeke Johannesburg Hospital
Johannesburg, South Africa
Hospital General Univ. Gregorio Maranon
Madrid, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Adana Acibadem Hospital; Pediatric Hematology
Adana, Turkey (Türkiye)
Cukurova University Medical Faculty Balcali Hospital
Adana, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, Turkey (Türkiye)
Central Middlesex Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom