Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)

NCT07697599 — Phase 3, Recruiting, 1908 participants, Regeneron Pharmaceuticals

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A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)

Registry	NCT07697599, acronym ROXI-PEAK
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	1908 (Estimated)
Sponsor	Regeneron Pharmaceuticals (Industry)
Conditions	Venous Thromboembolism (VTE)
Interventions	REGN7508, REGN9933, Placebo (Drug)
Dates	start 2026-09-07, primary completion 2029-06-25 (estimated), completion 2029-09-18 (estimated), first posted 2026-07-13, last updated 2026-09-29
Locations	1 site in Georgia

-Summary

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter \[PICC\]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism \[VTE\]) and lead to serious health problems or be life threatening.

The aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
* If the study drugs affect the ability of the blood to clot normally

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+Arms and interventions

Arm	Type	Interventions
REGN7508	Experimental	Drug: REGN7508
REGN9933	Experimental	Drug: REGN9933
Placebo	Placebo comparator	Drug: Placebo

REGN7508 (Drug), also known as cenvacibart: Administered per the protocol
REGN9933 (Drug), also known as amrecibart: Administered per the protocol
Placebo (Drug): Administered per the protocol

+Outcome measures

Primary outcomes

Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE] [Approximately 6 months]
Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding [Approximately 6 months]

Secondary outcomes

Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death] [Approximately 6 months]
Time-to-first event of symptomatic DVT [Approximately 6 months]
Time-to-first event of symptomatic non-fatal PE [Approximately 6 months]
Time-to-first event of VTE-related death [Approximately 6 months]
Time-to-first event of incidental VTE [Approximately 6 months]
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT [Approximately 6 months]
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery) [Approximately 6 months]
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound) [Approximately 6 months]
Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Up to approximately 9 months]
Severity of TEAEs [Up to approximately 9 months]
Concentrations of REGN7508 [Up to approximately 9 months]
Concentrations of REGN9933 [Up to approximately 9 months]
Change from baseline in activated Partial Thromboplastin Time (aPTT) [Up to approximately 9 months]
Change from baseline in Prothrombin Time (PT) [Up to approximately 9 months]
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 [Up to approximately 9 months]
Magnitude of ADA to REGN7508 [Up to approximately 9 months]
Occurrence of ADA to REGN9933 [Up to approximately 9 months]
Magnitude of ADA to REGN9933 [Up to approximately 9 months]

+Eligibility

Sex: All, ages: 15 Years to any

Key Inclusion Criteria:

1. Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol
2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
3. Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
4. Weighs at least 40 kg during the screening period

Key Exclusion Criteria:

1. Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
2. Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
3. Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
4. Has current or history of known brain tumors or brain metastases
5. Has any major cardiovascular event within approximately the past 30 days prior to study administration
6. Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

+Locations (1)

Facility	City	Country	Status
Arensia Exploratory Medicine at the Research Institute of Clinical Medicine	Tbilisi	Georgia	Recruiting

+Investigators

Clinical Trial Management, Study director, Regeneron Pharmaceuticals

My Notes

Public

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