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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004840-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crovalimab | Experimental | Participants will receive a single intravenous (IV) infusion of Crovalimab based on body weight. |
|
| Placebo | Placebo Comparator | Participants will receive a single IV infusion of matching Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crovalimab | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Baseline up to Day 84 | |
| Percentage of Participants with Infusion-Related Reactions and Hypersensitivity | Baseline up to Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Improvement of the Primary Acute Uncomplicated VOE From Baseline | Baseline up to Day 84 | |
| Total Cumulative Opioid Dose From Baseline | Baseline up to Day 84 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children'S Healthcare of Atlanta | Atlanta | Georgia | 30329 | United States | ||
| Icahn School of Medicine at Mount Sinai |
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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| Placebo | Drug | Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab |
|
| Time to Discontinuation of all Parenteral Opioids From Baseline |
| Baseline up to Day 84 |
| Time to Readiness For Hospital Discharge From Baseline | Baseline up to Day 84 |
| Time to Hospital Discharge From Baseline | Baseline up to Day 84 |
| Time to a Confirmed Decrease in Pain Score of at Least 2 Points From the Maximal Pre-dose Pain Score | Baseline up to Day 84 |
| Change in Pain Score From the Maximal Pre-dose Pain Score to the Score at Hospital Discharge | Baseline up to Day 84 |
| Percentage of Participants who Develop Acute Chest Syndrome (ACS) | Baseline up to Day 28 |
| Percentage of Participants Requiring Intensive Care Unit (ICU)/Critical Care Admission for SCD-related Complications | Baseline up to Day 84 |
| Percentage of Participants Requiring Blood Transfusion for SCD-related Complications | Baseline up to Day 84 |
| Readmission Rate for a VOE or VOE-related Event Within 28 days of Discharge of the Primary Acute Uncomplicated VOE | Baseline up to Day 84 |
| Serum Concentrations of Crovalimab Over Time | Baseline up to Day 84 |
| Change in PD Biomarkers Including Complement Activity (CH50) Over Time | Assessed by a Liposome Immunoassay (LIA) | Baseline up to Day 84 |
| Change Over Time in Free C5 Concentration | Baseline up to Day 84 |
| Change Over Time in Soluble Complement 5b 9 (sC5b-9) Concentration | Baseline up to Day 84 |
| Percentage of Participants with Anti-Drug Antibodies to Crovalimab | Baseline up to Day 84 |
| New York |
| New York |
| 10029 |
| United States |
| Hospital Sao Rafael - HSR | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | Brazil |
| CHU Henri Mondor | Créteil | 64010 | France |
| Azienda Ospedaliera di Verona-Policlinico G.B. Rossi | Verona | Veneto | 37134 | Italy |
| International Cancer Institute (ICI) | Eldoret | 30100 | Kenya |
| Gertrude's Children Hospital | Nairobi | Kenya |
| American University of Beirut - Medical Center | Beirut | 1107 2020 | Lebanon |
| Hopital Nini | Tripoli | Lebanon |
| Amsterdam UMC Location VUMC | Amsterdam | 1081 HV | Netherlands |
| Charlotte Maxeke Johannesburg Hospital | Johannesburg | 2193 | South Africa |
| Hospital General Univ. Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Hammersmith Hospital | London | W12 OHS | United Kingdom |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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