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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521154-42-00 | EU Trial (CTIS) Number |
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This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD.
The primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anumigilimab | Experimental | Safety of Anumigilimab (CSL324) in Adults with Sickle Cell Disease (SCD) |
|
| Placebo | Placebo Comparator | Participants will receive matching volume of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anumigilimab | Biological | Participants will receive anumigilimab, escalated to a maximum dose guided by absolute neutrophil count (ANC) and safety concerns. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP) | From baseline up to Week 75 | |
| Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP | From baseline up to Week 75 | |
| Number of participants with Adverse Events of Special Interest (AESI) | The following AEs are to be reported as AESI: neutropenia (Common Terminology Criteria for Adverse Events [CTCAE] Grade 3 or 4), severe infection and neutropenic fever. | From baseline up to Week 75 |
| Percentage of participants with AESI | The following AEs are to be reported as AESI: neutropenia (CTCAE Grade 3 or 4), severe infection and neutropenic fever. | From baseline up to Week 75 |
| Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs | From baseline up to Week 75 | |
| Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs | From baseline up to Week 75 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of Anumigilimab | From the first dose of anumigilimab to Week 65 | |
| Annualized rate of Vaso-occlusive crisis (VOC) (medical facility) | VOC (medical facility) is defined as VOC that results in a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Registration Coordinator | Contact | +1 610-878-4697 | clinicaltrials@cslbehring.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Medical Center | Recruiting | Little Rock | Arkansas | 72202 | United States | |
| The Foundation for Sickle Cell Disease |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000740 | Anemia |
| D030342 | Genetic Diseases, Inborn |
| D000098644 | Vaso-Occlusive Crises |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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This is a double blind, placebo controlled study.
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| Placebo | Drug | Volume matched saline will be administered SC. |
|
| During the maintenance period from Week 13 to Week 65 |
| Recruiting |
| Hollywood |
| Florida |
| 33023-6703 |
| United States |
| Center for Cancer and Blood Disorders | Recruiting | Bethesda | Maryland | 20817 | United States |
| Southern Specialty Research | Recruiting | Flowood | Mississippi | 39232 | United States |
| Jacobi Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
| D006453 | Hemoglobinopathies |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |