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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522980-14-00 | EU Trial (CTIS) Number |
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The study was discontinued due to a strategic business/portfolio decision by the sponsor and was not related to any medical or safety issue.
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The main purpose of this study is to evaluate the efficacy of crovalimab compared with placebo as an add-on therapy to vitamin K antagonist (VKA) in participants with APS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crovalimab + VKA | Experimental | Participants will receive 3 loading doses of crovalimab, 680 milligrams (mg) or 1020 mg, as a subcutaneous (SC) injection based on their body weight (BW) at Weeks 1, 2 and 3 followed by maintenance doses, every 4 weeks (Q4W) from Week 5 until arterial thrombosis, venous thromboembolism or cardiovascular death. Participants will also receive VKA with a target internal normalized ratio (INR) based on investigator's discretion and local guidance. |
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| Placebo + VKA | Placebo Comparator | Participants will receive 3 doses of placebo as a SC injection with equal volume dosing as the weight-based crovalimab at Weeks 1, 2, and 3, followed by Q4W doses, as a SC injection, from Week 5 until arterial thrombosis, venous thromboembolism, or cardiovascular death. Participants will also receive VKA with a target INR based on the investigator's discretion and local guidance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crovalimab | Drug | Crovalimab will be administered at a dose of 680 mg (for participants with BW ≥ 40 kilograms [kg] to < 100 kg) or 1020 mg (for participants with BW ≥ 100 kg), as a SC injection, at Weeks 1, 2, and 3 and Q4W from Week 5 onwards. |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to First Occurrence of Objectively Confirmed Arterial Thrombosis, Venous Thromboembolism or Cardiovascular Death | Up to approximately 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to the First Occurrence of Objectively Confirmed Venous Thromboembolism | Up to approximately 4.5 years | |
| Time From Randomization to the First Occurrence of Objectively Confirmed Arterial Thrombosis | Up to approximately 4.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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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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| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo | Drug | Placebo matching crovalimab will be administered as per the schedule specified in the respective arm. |
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| VKA | Drug | Dose administration of VKA will be in accordance with the local prescribing information for the respective product. The VKA regimen will be titrated to a therapeutic target INR based on investigator discretion and local standard of care (SOC). |
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| Percentage of Participants With Adverse Events (AEs) With Severity Determined According to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) | Up to approximately 4.5 years |
| Percentage of Participants With Injection Site Reactions and Hypersensitivity | Up to approximately 4.5 years |
| Percentage of Participants With Infections and Severity of Infection | Up to approximately 4.5 years |
| Percentage of Participants With AEs Leading to Study Drug Discontinuation | Up to approximately 4.5 years |
| Serum Concentrations of Crovalimab Over Time | Up to approximately 4.5 years |