Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
- 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
- Acronym
- ROXI-PEAK
- Short title
- Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
- Official title
- 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)
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2029-09-21
- First posted
- 2026-07-13
- Registry last updated
- 2026-07-13
- Primary completion date
- 2029-06-25
- Start date
- 2026-08-20
- Participants
- 1,908
- Participant count basis
- Estimated
- Planned participants
- 1,908
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Regeneron Pharmaceuticals
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07697599
- ClinicalTrials.gov ID
- NCT07697599
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Timeframe: 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
Timeframe: Approximately 6 months
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]
Timeframe: Approximately 6 months
Time-to-first event of symptomatic DVT
Timeframe: Approximately 6 months
Time-to-first event of symptomatic non-fatal PE
Timeframe: Approximately 6 months
Time-to-first event of VTE-related death
Timeframe: Approximately 6 months
Time-to-first event of incidental VTE
Timeframe: Approximately 6 months
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Timeframe: Approximately 6 months
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
Timeframe: Approximately 6 months
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
Timeframe: Approximately 6 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 9 months
Severity of TEAEs
Timeframe: Up to approximately 9 months
Concentrations of REGN7508
Timeframe: Up to approximately 9 months
Concentrations of REGN9933
Timeframe: Up to approximately 9 months
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Timeframe: Up to approximately 9 months
Change from baseline in Prothrombin Time (PT)
Timeframe: Up to approximately 9 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Timeframe: Up to approximately 9 months
Magnitude of ADA to REGN7508
Timeframe: Up to approximately 9 months
Occurrence of ADA to REGN9933
Timeframe: Up to approximately 9 months
Magnitude of ADA to REGN9933
Timeframe: Up to approximately 9 months
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 15 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
- 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
- Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
- Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
- Weighs at least 40 kg during the screening period
Key Exclusion Criteria:
- Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
- Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
- Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
- Has current or history of known brain tumors or brain metastases
- Has any major cardiovascular event within approximately the past 30 days prior to study administration
- Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Other registry identifiers
- 2026-525288-42-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Thrombotic disease
- Venous thromboembolism Primary condition