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Trial record 1 of 1 for:    NCT04912869
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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). (CROSSWALK-a)

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ClinicalTrials.gov Identifier: NCT04912869
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Crovalimab Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : March 26, 2022
Estimated Primary Completion Date : January 14, 2025
Estimated Study Completion Date : July 14, 2025


Arm Intervention/treatment
Experimental: Crovalimab
Participants will receive a single intravenous (IV) infusion of Crovalimab based on body weight.
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).

Placebo Comparator: Placebo
Participants will receive a single IV infusion of matching Placebo.
Drug: Placebo
Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Day 322 ]
  2. Percentage of Participants with Infusion-Related Reactions and Hypersensitivity [ Time Frame: Baseline up to Day 84 ]

Secondary Outcome Measures :
  1. Time to improvement of the primary acute uncomplicated VOE from Baseline [ Time Frame: Baseline up to Day 84 ]
  2. Total cumulative opioid dose from Baseline [ Time Frame: Baseline up to Day 84 ]
  3. Time to discontinuation of all parenteral opioids from baseline [ Time Frame: Baseline up to Day 84 ]
  4. Time to readiness for hospital discharge from baseline [ Time Frame: Baseline up to Day 84 ]
  5. Time to hospital discharge from baseline [ Time Frame: Baseline up to Day 84 ]
  6. Time to a confirmed decrease in pain score of at least 2 points from the maximal pre-dose pain score [ Time Frame: Baseline up to Day 84 ]
  7. Change in pain score from the maximal pre-dose pain score to the score at hospital discharge [ Time Frame: Baseline up to Day 84 ]
  8. Percentage of Participants who develop Acute Chest Syndrome (ACS) [ Time Frame: Baseline up to Day 28 ]
  9. Percentage of Participants requiring intensive care unit (ICU)/critical care admission for SCD-related complications [ Time Frame: Baseline up to Day 84 ]
  10. Percentage of Participants requiring blood transfusion for SCD-related complications [ Time Frame: Baseline up to Day 84 ]
  11. Readmission rate for a VOE or VOE-related event within 28 days of discharge of the primary VOE [ Time Frame: Baseline up to Day 84 ]
  12. Serum Concentrations of Crovalimab over time [ Time Frame: Baseline up to Day 84 ]
  13. Change in PD biomarkers including complement activity (CH50) over time [ Time Frame: Baseline up to Day 84 ]
    Assessed by a Liposome Immunoassay (LIA)

  14. Change over time in free C5 concentration [ Time Frame: Baseline up to Day 84 ]
  15. Change over time in soluble complement 5b 9 (sC5b-9) concentration [ Time Frame: Baseline up to Day 84 ]
  16. Percentage of Participants with Anti-Drug Antibodies to Crovalimab [ Time Frame: Baseline up to Day 84 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 sickle cell 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.

Exclusion Criteria:

  • More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit.
  • Pain related to the current VOE ongoing for >48 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.
  • Evidence or high suspicion of a severe systemic infection.
  • Major surgery and/or hospitalization for any reason within 30 days.
  • History of Neisseria meningitidis infection within 6 months prior.
  • Known HIV infection with a documented CD4 count <200 cells/µL.
  • Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol.
  • Immunized with a live attenuated vaccine within 30 days.
  • History of hematopoietic stem cell transplant.
  • Known or suspected hereditary complement deficiency.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04912869


Contacts
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Contact: Reference Study ID Number: BO42452 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, North Carolina
East Carolina University; Brody School of Medicine Recruiting
Greenville, North Carolina, United States, 27834
Brazil
Hospital Sao Rafael - HSR Recruiting
Salvador, BA, Brazil, 41253-190
Hospital das Clinicas - UFRGS Recruiting
Porto Alegre, RS, Brazil, 90035-903
Hospital de Base de Sao Jose do Rio Preto Recruiting
Sao Jose do Rio Preto, SP, Brazil, 15090-000
France
CHU Henri Mondor; Service de médecine interne Recruiting
Créteil, France, 94010
Hôpital Saint Eloi; Service de Médecine interne Recruiting
Montpellier, France, 34295
Italy
Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Medicina Interna Recruiting
Verona, Veneto, Italy, 37134
Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia Withdrawn
Barcelona, Spain, 08035
Hospital General Univ. Gregorio Maranon Recruiting
Madrid, Spain, 28009
Hospital Universitario Virgen del Rocio; Servicio de Hematologia Recruiting
Sevilla, Spain, 41013
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04912869    
Other Study ID Numbers: BO42452
2020-004840-27 ( EudraCT Number )
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
Vaso-occlusive episodes
Pain crisis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn