A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 26, 2022

Primary Completion Date

December 23, 2024

Study Completion Date

August 15, 2025

Conditions
Sickle Cell Disease
Interventions
DRUG

Crovalimab

Crovalimab will be administered as a single dose of 1000 milligrams (mg) IV (for participants with a body weight between 40 kilograms (kg) and 100 kg) or 1500 mg IV (for participants with a body weight \>=100 kg).

DRUG

Placebo

Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab

Trial Locations (16)

2193

Charlotte Maxeke Johannesburg Hospital, Johannesburg

10029

Icahn School of Medicine at Mount Sinai, New York

28009

Hospital General Univ. Gregorio Maranon, Madrid

30100

International Cancer Institute (ICI), Eldoret

30329

Children'S Healthcare of Atlanta, Atlanta

37134

Azienda Ospedaliera di Verona-Policlinico G.B. Rossi, Verona

41013

Hospital Universitario Virgen del Rocio, Seville

50009

Hospital Universitario Miguel Servet, Zaragoza

64010

CHU Henri Mondor, Créteil

41253-190

Hospital Sao Rafael - HSR, Salvador

Unknown

Hospital das Clinicas - UFRGS, Porto Alegre

Gertrude's Children Hospital, Nairobi

Hopital Nini, Tripoli

1107 2020

American University of Beirut - Medical Center, Beirut

1081 HV

Amsterdam UMC Location VUMC, Amsterdam

W12 OHS

Hammersmith Hospital, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY