Venous Thromboembolism (VTE)Phase 3ROXI-PEAKNCT07697599
Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)
A Phase 3 study testing REGN7508 and REGN9933 in people with Venous Thromboembolism (VTE), run by Regeneron Pharmaceuticals at 1 site in Georgia.
Trial 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]). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Venous Thromboembolism (VTE)
- What is being tested?
- REGN7508 and REGN9933
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,908 participants
- Where
- 1 siteGeorgia
- Study dates
- 7 Sep 2026to 18 Sep 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia1 site, 1 recruiting
- Recruiting
Arensia Exploratory Medicine at the Research Institute of Clinical Medicine
Tbilisi, 0112
About this study
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)
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.
Read more
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
- Conditions
- Venous Thromboembolism (VTE)
- Being tested
- REGN7508, REGN9933, Placebo
- Keywords
- Peripherally Inserted Central Catheter (PICC), Blood clots
- Medical subject headings
- Venous Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7508Drug
Also called cenvacibart
Administered per the protocol
REGN9933Drug
Also called amrecibart
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| REGN7508 | Experimental | Not described Receives: Drug: REGN7508 |
| REGN9933 | Experimental | Not described Receives: Drug: REGN9933 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Measured: 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
Measured: Approximately 6 months
Secondary outcomes (18)
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]
Measured: Approximately 6 months
Time-to-first event of symptomatic DVT
Measured: Approximately 6 months
Time-to-first event of symptomatic non-fatal PE
Measured: Approximately 6 months
Time-to-first event of VTE-related death
Measured: Approximately 6 months
Time-to-first event of incidental VTE
Measured: Approximately 6 months
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Measured: Approximately 6 months
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
Measured: Approximately 6 months
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
Measured: Approximately 6 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately 9 months
Severity of TEAEs
Measured: Up to approximately 9 months
Concentrations of REGN7508
Measured: Up to approximately 9 months
Concentrations of REGN9933
Measured: Up to approximately 9 months
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Measured: Up to approximately 9 months
Change from baseline in Prothrombin Time (PT)
Measured: Up to approximately 9 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Measured: Up to approximately 9 months
Magnitude of ADA to REGN7508
Measured: Up to approximately 9 months
Occurrence of ADA to REGN9933
Measured: Up to approximately 9 months
Magnitude of ADA to REGN9933
Measured: Up to approximately 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start7 Sep 2026
- Primary completion25 Jun 2029 (estimated)
- Study completion18 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,908 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697599
- Sponsor's protocol ID
- R7508-DVT-25103
- Other IDs
- 2026-525288-42-00
- Acronym
- ROXI-PEAK
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.