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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004839-25 | EudraCT Number | ||
| 2022-502542-28-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crovalimab | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crovalimab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of medical facility VOEs (AVR) | Baseline up to Week 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of home VOE | Baseline up to Week 49 | |
| Annualized rate of uncomplicated medical facility VOE | Baseline up to Week 49 | |
| Annualized rate of Acute Chest Syndrome (ACS) |
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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 Hospital of Michigan | Detroit | Michigan | 48201 | United States | ||
| Mississippi Center for Advanced Medicine |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing.
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| Placebo | Drug | Matching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab. |
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| Baseline to up Week 49 |
| Annualized rate of days hospitalized for medical facility VOE | Baseline up to Week 49 |
| Annualized rate of days hospitalized for treatment of non-VOE complications of SCD | Baseline up to Week 49 |
| Time to first medical facility VOE from randomization | Baseline up to Week 49 |
| Change in urinary albumin-creatinine ratio | Baseline up to Week 49 |
| Change in Tricuspid Regurgitant Jet Velocity (TRV) | Baseline up to Week 49 |
| Percentage of Participants with TRV >2.5 m/s | Week 49 |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Score in Adults | Baseline up to Week 49 |
| Percentage of Participants with Adverse Events (AEs) | Up to 91 weeks |
| Serum Concentrations of Crovalimab over time | Baseline up to Week 49 |
| Percentage of Participants with Anti-Drug Antibodies to Crovalimab | Baseline up to Week 49 |
| Madison |
| Mississippi |
| 39110 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Hospital Sao Rafael - HSR | Salvador | Estado de Bahia | 41253-190 | 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 | 18618-970 | Brazil |
| Hospital das Clínicas Faculdades Médicas de Ribeirão Preto | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Beneficencia Portuguesa de Sao Paulo | São Paulo | São Paulo | 01323-900 | Brazil |
| HEMORIO | Rio de Janeiro | 20211-030 | Brazil |
| Hospital Samaritano | São Paulo | 01232-010 | Brazil |
| CHU Henri Mondor | Créteil | 64010 | France |
| Università degli Studi della Campania Luigi Vanvitelli | Naples | Campania | 80138 | Italy |
| 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 |
| 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 Miguel Servet | Zaragoza | 50009 | Spain |
| Adana Acibadem Hospital; Pediatric Hematology | Adana | 01130 | Turkey (Türkiye) |
| Cukurova University Medical Faculty Balcali Hospital | Adana | 1330 | Turkey (Türkiye) |
| Mersin Universitesi Tip Fakultesi Hastanesi | Mersin | 33343 | Turkey (Türkiye) |
| Central Middlesex Hospital | London | NW10 7NS | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | 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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