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NCT04912869CompletedPhase 1

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).

A Phase IB Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD)

Source: ClinicalTrials.gov · Last updated 26 Aug 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (actual)
First submitted
2 Jun 2021
Start date
26 Mar 2022
Primary completion date
23 Dec 2024
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04912869
EU CT number
2022-502546-26-00
EudraCT number
2020-004840-27

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 30
  • From 26 Mar 2022 to the primary completion date, 23 Dec 2024
  • 17 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit.
  • Major surgery and/or hospitalization for any reason within 30 days.
  • History of Neisseria meningitidis infection within 6 months prior.
  • Immunized with a live attenuated vaccine within 30 days.
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration.
  • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater.

Other illness

  • Evidence or high suspicion of a severe systemic infection.
  • History of hematopoietic stem cell transplant.

Lab values

  • Known HIV infection with a documented CD4 count \<200 cells/µL.

Other

  • Pain related to the current VOE ongoing for \>36 hours.
  • Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism.
  • Pain atypical of an acute uncomplicated VOE.
  • Evidence of or suspicion of ACS.
  • Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol.
  • Known or suspected hereditary complement deficiency.

Who the study is looking for

  • Body weight \>=40 kg.
  • Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
  • Vaccination against Neisseria Meningitidis serotypes A, C, W, and Y.
  • Vaccinations against H. influenzae type B and S. pneumoniae.
  • Participants vaccinated against SARS-CoV-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine.
  • Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics.
  • Adequate hepatic and renal function.
  • Hemoglobin \>=5 grams/deciliter (g/dL)
  • Platelet count \>=100,000/microliter (µL)
  • Participants receiving SCD-directed therapies must be on a stable dose for \>=28 days.
  • For female participants of childbearing potential, an agreement to remain abstinent or use contraception for 322 days (approximately 10.5 months) after the dose of study treatment.

Age in the registry: 12 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital das Clinicas - UFRGS
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Porto AlegreBrazilUnknown status
Hospital Sao Rafael - HSR
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SalvadorBrazilUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospital Unviersitario Miguel Servet
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ZaragozaSpainCompleted
Assistance Publique Hopitaux De Paris
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CreteilFranceCompleted
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceCompleted
Hammersmith Hospital
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LondonUnited KingdomUnknown status
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyCompleted
International Cancer Institute (ICI)
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EldoretKenyaUnknown status
Gertrude's Children Hospital
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NairobiKenyaUnknown status
American University of Beirut Medical Center
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BeirutLebanonUnknown status
Hopital Nini
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TripoliLebanonUnknown status
Amsterdam UMC
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AmsterdamNetherlandsCompleted
Children's Healthcare of Atlanta
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AtlantaUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Charlotte Maxeke Johannesburg Hospital
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JohannesburgSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.