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ACTIVE NOT RECRUITING
NCT05075824
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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