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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID: NCT05075824
Run by: Hoffmann-La Roche
People needed: 95
Starts: 2022-03-09
Expected to finish: 2026-04-09
Last updated by the study team: 2026-04-30

Who can join

Age: 12 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Body weight >=40 kg.
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.

You may not qualify if…

History of hematopoietic stem cell transplant.
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.

Where it is running

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)

Full record on ClinicalTrials.gov

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