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)
NCT ID: NCT05075824
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2022-03-09
2026-04-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Crovalimab
Participants will receive a loading series of Crovalimab comprised of an intravenous (IV) loading dose on Day 1, followed by weekly Crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance SC dosing will begin at Week 5 and will continue every 4 weeks (Q4W) thereafter for a total of 48 weeks of treatment.
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
Participants will receive matching Placebo administered by IV infusion and SC injection over the same duration as Crovalimab, for a total of 48 weeks of treatment.
Placebo
Matching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
* Two or more (\>=2) to \<=10 documented VOEs in the 12 months prior to randomisation.
* If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons.
* If receiving erythropoietin, the participant must have been prescribed this medication for the preceding 3 months and be dose-stabilised for at least 3 months prior to study enrollment.
* Vaccination against N. meningitides serotypes A, C, W, and Y and Vaccinations against H. influenza type B and S. pneumonia.
* Participants who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation.
* Adequate hepatic and renal function.
* For women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of study treatment.
Exclusion Criteria
* Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study.
* History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment.
* Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial.
* Hemoglobin \<6 g/dL.
* Known or suspected hereditary complement deficiency.
* Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration.
* Presence of fever (\>=38 degrees Celsius) within 7 days before the first drug administration.
* Immunised with a live attenuated vaccine within 1 month before first drug administration.
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 10.5 months after the final dose of study treatment.
* Known HIV infection with documented CD4 count \<200 cells/microliter within 24 weeks prior to screening.
* History of N. meningitidis infection within the prior 6 months.
12 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Napoli, 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
Countries
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Other Identifiers
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2020-004839-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502542-28-00
Identifier Type: CTIS
Identifier Source: secondary_id
BO42451
Identifier Type: -
Identifier Source: org_study_id