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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508602-14-00 | Other Identifier | EU CT Number |
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This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement (TKR) surgery.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after unilateral total knee replacement surgery.
The study is looking at several other research questions, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7508 | Experimental |
| |
| Enoxaparin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered by single intravenous (IV) dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) | Composite endpoint that includes asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out. | Through day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding | International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol | Through day 12 |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multi-profile Hospital for Active Treatment Hearth and Brain EAD | Pleven | 5800 | Bulgaria | |||
| Multiprofile Hospital For Active Treatment Park Hospital Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41218619 | Derived | Weitz JI, Kithcart AP, O'Brien MP, Levy O, Marin E, Onisko M, Mohammadi KA, Li D, Meagher KA, Chang HH, Olenchock BA, Gutstein DE, Segers A, Roberts RS, Bonaca MP, Raskob GE. Efficacy and safety of REGN9933A2 and REGN7508Cat for preventing postoperative venous thromboembolism (ROXI-VTE-I and ROXI-VTE-II): two randomised, open-label, phase 2 trials. Lancet. 2025 Nov 29;406(10519):2551-2563. doi: 10.1016/S0140-6736(25)02097-5. Epub 2025 Nov 8. |
| Label | URL |
|---|---|
| A Plain Language Summary is available on TrialSummaries.com | View source |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Of 201 participants screened, 179 participants met eligibility criteria and were randomized. All 179 randomized participants received study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | REGN7508 | Administered by single intravenous (IV) infusion |
| FG001 | Enoxaparin | Administered by daily subcutaneous (SC) injections through the time of venography (or day 12, whichever was earlier) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2024 | Jan 13, 2026 |
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| Enoxaparin |
| Drug |
Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier) |
|
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A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. |
| Through day 75 |
| Percentage of Participants With Major VTE | Major VTE is a composite endpoint that includes: proximal DVT; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal PE including unexplained death for which PE cannot be ruled out. | Through day 12 |
| Percentage of Participants With Deep Venous Thrombosis (DVT) | DVT measured by venography of the operated leg | Through day 12 |
| Concentrations of Total REGN7508 in Serum | Days 1, 5, 10, 30 and 75 |
| Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | aPTT was used to measure the anticipated anticoagulant effect of REGN7508. Fold change is based on the follow-up value/baseline value within an arm. | Days 1, 5, 10, 30, 75 |
| Fold Change From Baseline in Prothrombin Time (PT) | PT is a measure of extrinsic and/or common pathway function. Fold change is based on the follow-up value/baseline value within an arm. | Days 1, 5, 10, 30, 75 |
| Number of Participants With Anti-REGN7508 Antibodies by Status | Immunogenicity characterized by anti-drug antibody (ADA) status | Through end of study; approximately Day 75 |
| Number of Participants With Treatment-Emergent or Treatment-Boosted Anti-REGN7508 Antibodies by Maximum Titer | Immunogenicity characterized per by ADA status | Through end of study; approximately Day 75 |
| Plovdiv |
| 4002 |
| Bulgaria |
| Budai Irgalmasrendi Korhaz | Budapest | 1027 | Hungary |
| Szolnoki MAV Hospital | Szolnok | 5000 | Hungary |
| Vidzemes Hospital | Valmiera | Valmieras Aprinkis | LV-4201 | Latvia |
| Liepaja Regional Hospital | Liepāja | LV-3414 | Latvia |
| Riga's 2nd Hospital | Riga | LV-1004 | Latvia |
| Hospital of Traumatology and Orthopaedics | Riga | LV-1005 | Latvia |
| Orto Klinika | Riga | LV-1005 | Latvia |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik | Kaunas | Kaunas County | LT-50161 | Lithuania |
| Lithuanian University of Health Sciences Kaunas Hospital | Kaunas | LT-48142 | Lithuania |
| Klaipeda University Hospital | Klaipėda | LT-92288 | Lithuania |
| Specjalistyczny Szpital im. E. Szczeklika w Tarnowie | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Clinic of Orthopaedics and Paediatric Orthopaedics | Lodz | Łódź Voivodeship | 92-213 | Poland |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set (SAF): All randomized participants who received any study drug; it is based on the treatment received (as treated).
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| ID | Title | Description |
|---|---|---|
| BG000 | REGN7508 | Administered by single intravenous (IV) infusion |
| BG001 | Enoxaparin | Administered by daily subcutaneous (SC) injections through the time of venography (or day 12, whichever was earlier) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) | Composite endpoint that includes asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out. | Modified Intention to Treat Population (mITT): Randomized participants that had either an evaluable venogram, a confirmed episode of venous thromboembolism, or both. | Posted | Number | percentage of participants | Through day 12 |
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| Secondary | Number of Participants With Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding | International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol | mITT population | Posted | Count of Participants | Participants | Through day 12 |
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| Secondary | Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) | A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. | Safety Analysis Set (SAF): All randomized participants who received any study drug; it is based on the treatment received (as treated). | Posted | Number | percentage of participants | Through day 75 |
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| Secondary | Percentage of Participants With Major VTE | Major VTE is a composite endpoint that includes: proximal DVT; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal PE including unexplained death for which PE cannot be ruled out. | mITT population | Posted | Number | percentage of participants | Through day 12 |
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| Secondary | Percentage of Participants With Deep Venous Thrombosis (DVT) | DVT measured by venography of the operated leg | mITT population | Posted | Number | percentage of participants | Through day 12 |
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| Secondary | Concentrations of Total REGN7508 in Serum | All participants in the REGN7508 treatment group who received study drug and who had at least 1 non-missing result following the first dose of study drug and who were evaluable at time points specified for this outcome measure. | Posted | Mean | Standard Deviation | milligrams per liter (mg/L) | Days 1, 5, 10, 30 and 75 |
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| Secondary | Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | aPTT was used to measure the anticipated anticoagulant effect of REGN7508. Fold change is based on the follow-up value/baseline value within an arm. | All randomized participants who received any study drug and who had at least 1 non-missing pharmacodynamic (PD) result following the first dose of study drug and who were evaluable at time points specified for this outcome measure. | Posted | Mean | Standard Deviation | Fold Change | Days 1, 5, 10, 30, 75 |
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| Secondary | Fold Change From Baseline in Prothrombin Time (PT) | PT is a measure of extrinsic and/or common pathway function. Fold change is based on the follow-up value/baseline value within an arm. | All randomized participants who received any study drug and who had at least 1 non-missing pharmacodynamic (PD) result following the first dose of study drug and who were evaluable at time points specified for this outcome measure. | Posted | Mean | Standard Deviation | Fold Change | Days 1, 5, 10, 30, 75 |
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| Secondary | Number of Participants With Anti-REGN7508 Antibodies by Status | Immunogenicity characterized by anti-drug antibody (ADA) status | Participants who received any REGN7508 and who had at least 1 non-missing anti-REGN7508 antibody result following the first dose of study drug. | Posted | Count of Participants | Participants | Through end of study; approximately Day 75 |
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| Secondary | Number of Participants With Treatment-Emergent or Treatment-Boosted Anti-REGN7508 Antibodies by Maximum Titer | Immunogenicity characterized per by ADA status | Posted | Count of Participants | Participants | Through end of study; approximately Day 75 |
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From signing of informed consent to end of study (up to Day 75)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | REGN7508 | Administered by single intravenous (IV) infusion | 0 | 120 | 2 | 120 | 8 | 120 |
| EG001 | Enoxaparin | Administered by daily subcutaneous (SC) injections through the time of venography (or day 12, whichever was earlier) | 0 | 59 | 0 | 59 | 6 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
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The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2024 | Jan 13, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories |
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| Day 1 (1 hour post REGN7508 dose) |
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| Day 5 |
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| Day 10 |
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| Day 30 |
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| Day 75 |
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| Title | Denominators | Categories | ||||||||||
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