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Trial record 1 of 1 for:    NCT05075824
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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) (CROSSWALK-c)

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ClinicalTrials.gov Identifier: NCT05075824
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : December 8, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Crovalimab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 9, 2022
Estimated Primary Completion Date : July 26, 2024
Estimated Study Completion Date : January 10, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: 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.
Drug: Placebo
Matching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab.




Primary Outcome Measures :
  1. Annualized rate of medical facility VOEs (AVR) [ Time Frame: Baseline up to Week 49 ]

Secondary Outcome Measures :
  1. Annualized rate of home VOE [ Time Frame: Baseline up to Week 49 ]
  2. Annualized rate of uncomplicated medical facility VOE [ Time Frame: Baseline up to Week 49 ]
  3. Annualized rate of Acute Chest Syndrome (ACS) [ Time Frame: Baseline to up Week 49 ]
  4. Annualized rate of days hospitalized for medical facility VOE [ Time Frame: Baseline up to Week 49 ]
  5. Annualized rate of days hospitalized for treatment of non-VOE complications of SCD [ Time Frame: Baseline up to Week 49 ]
  6. Time to first medical facility VOE from randomization [ Time Frame: Baseline up to Week 49 ]
  7. Change in urinary albumin-creatinine ratio [ Time Frame: Baseline up to Week 49 ]
  8. Change in Tricuspid Regurgitant Jet Velocity (TRV) [ Time Frame: Baseline up to Week 49 ]
  9. Percentage of Participants with TRV >2.5 m/s [ Time Frame: Week 49 ]
  10. Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Score in Adults [ Time Frame: Baseline up to Week 49 ]
  11. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 91 weeks ]
  12. Serum Concentrations of Crovalimab over time [ Time Frame: Baseline up to Week 49 ]
  13. Percentage of Participants with Anti-Drug Antibodies to Crovalimab [ Time Frame: Baseline up to Week 49 ]


Information from the National Library of Medicine

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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.
  • 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:

  • 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.

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): NCT05075824


Contacts
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Contact: Reference Study ID Number: BO42451 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 Clínicas Faculdades Médicas de Ribeirão Preto Recruiting
Ribeirao Preto, SP, Brazil, 14051-140
Hospital de Base de Sao Jose do Rio Preto Recruiting
Sao Jose do Rio Preto, SP, Brazil, 15090-000
France
Hôpital Saint Eloi; Service de Médecine interne Recruiting
Montpellier, France, 34295
Italy
Università degli Studi della Campania Luigi Vanvitelli; UOC Ematologia ed oncologia pediatrica Recruiting
Napoli, Campania, Italy, 80138
Ospedale Galliera; S.S.D. Ematologia Recruiting
Genova, Liguria, Italy, 16128
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
Turkey
Adana Acibadem Hospital; Pediatric Hematology Recruiting
Adana, Turkey, 01130
Cukurova University Medical Faculty Balcali Hospital Recruiting
Adana, Turkey, 01330
Mustafa Kemal University Medical Faculty; Infection Recruiting
Hatay, Turkey, 31040
Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi Recruiting
Mersin, Turkey, 33110
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: NCT05075824    
Other Study ID Numbers: BO42451
2020-004839-25 ( EudraCT Number )
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/innovation/process/clinical -trials/data-sharing/).

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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