Venous ThromboembolismPhase 2ROXI-CATHNCT06299111
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
A Phase 2 study testing REGN9933 and REGN7508 in people with Venous Thromboembolism, run by Regeneron Pharmaceuticals at 23 sites in 6 countries.
Trial summary
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- REGN9933 and REGN7508
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 20 Sep 2024to 27 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
- Body weight ≥45 kg and ≤130 kg during the screening period
- International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
- Platelet count ≥100 x 10^9/L during the screening period as described in the protocol
Who cannot join
- Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant
- History of prior venous thrombosis in the arm in which the PICC is to be placed
- Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
- History of known thromboembolic disease or thrombophilia
- Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol
- Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
- Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders) as described in the protocol
- Note: Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
Israel7 sites
Soroka University Medical Center
Beersheba, Southern District, 84101
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102
Hadassah University Medical Center
Jerusalem, 91120
Lanadio Medical Center
Netanya, 4244916
Rabin Medical Center
Petah Tikva, 49100
Sheba Medical Center
Ramat Gan, 5265601
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Henry Ford Health System
Detroit, Michigan, 48202
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Mount Sinai Medical Center
New York, New York, 10029
Memorial Sloan Kettering
New York, New York, 10065
Canada4 sites
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
London Health Sciences Centre
London, Ontario, N6A 4L6
Lakeridge Health
Oshawa, Ontario, L1G 2B9
University Health Network
Toronto, Ontario, M5G 2M9
United Kingdom3 sites
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, Wales, CF14 4XW
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
University hospital Southampton
Southampton, Hampshire, SO16 6YD
Romania2 sites
Arensia Research Clinic
Bucharest, 011658
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, 400006
About this study
Official title: A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH)
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
- Conditions
- Venous Thromboembolism
- Being tested
- REGN9933, REGN7508, Placebo
- Keywords
- Anti-factor XI (FXI) monoclonal antibody, Venous Thromboembolism, Peripherally inserted central catheter
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN9933Drug
Intravenous (IV) single dose administered
REGN7508Drug
IV single dose administered
PlaceboDrug
IV single dose administered
| Study group | Role | What they receive |
|---|---|---|
| REGN9933 | Experimental | Randomized 1:1:1 Receives: Drug: REGN9933 |
| REGN7508 | Experimental | Randomized 1:1:1 Receives: Drug: REGN7508 |
| Placebo | Placebo comparator | Randomized 1:1:1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of confirmed VTE per central reading center (CRC) review
Measured: Through Day 14
Incidence of treatment-emergent adverse event (TEAEs)
Measured: Up to Day 100
Severity of TEAEs
Measured: Up to Day 100
Secondary outcomes (11)
Incidence of confirmed PICC associated venous thrombosis per CRC review
Measured: Through Day 14
Incidence of major bleeding
Measured: Through Day 14
Incidence of clinically relevant non-major (CRNM) bleeding
Measured: Through Day 14
Concentrations of REGN9933 in serum
Measured: Up to Day 75
Concentrations of REGN7508 in serum
Measured: Up to Day 75
Change in activated partial thromboplastin time (aPTT)
Measured: Up to Day 75
Change in prothrombin time (PT)
Measured: Up to Day 75
Incidence of anti-drug antibody (ADA) to REGN9933 over time
Measured: Up to Day 75
Magnitude of ADA to REGN9933 over time
Measured: Up to Day 75
Incidence of ADA to REGN7508 over time
Measured: Up to Day 75
Magnitude of ADA to REGN7508 over time
Measured: Up to Day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start20 Sep 2024
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
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
- NCT06299111
- Sponsor's protocol ID
- R9933-DVT-2308
- Other IDs
- 2023-508603-21-00, 2023
- Acronym
- ROXI-CATH
- Status last verified
- Apr 2026
- First submitted
- 1 Mar 2024
- Last updated
- 13 Apr 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH)
- ClinicalTrials.gov ID
- NCT06299111
- Acronym / sponsor ID
- ROXI-CATH / R9933-DVT-2308
- Conditions
- Venous Thromboembolism
- Keywords
- Anti-factor XI (FXI) monoclonal antibody, Venous Thromboembolism, Peripherally inserted central catheter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| REGN9933 | Experimental | Drug: REGN9933Randomized 1:1:1 |
| REGN7508 | Experimental | Drug: REGN7508Randomized 1:1:1 |
| Placebo | Placebo comparator | Drug: PlaceboRandomized 1:1:1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
- Body weight ≥45 kg and ≤130 kg during the screening period
- International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
- Platelet count ≥100 x 10^9/L during the screening period as described in the protocol
Key exclusion criteria (8 listed)
- Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant
- History of prior venous thrombosis in the arm in which the PICC is to be placed
- Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
- History of known thromboembolic disease or thrombophilia
- Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN9933Intravenous (IV) single dose administered | Drug | REGN9933 |
| REGN7508IV single dose administered | Drug | REGN7508 |
| PlaceboIV single dose administered | Drug | Placebo |
Primary outcome
Incidence of confirmed VTE per central reading center (CRC) review
Time frame: Through Day 14
Incidence of treatment-emergent adverse event (TEAEs)
Time frame: Up to Day 100
Severity of TEAEs
Time frame: Up to Day 100
11 secondary outcomes
Incidence of confirmed PICC associated venous thrombosis per CRC review
Time frame: Through Day 14
Incidence of major bleeding
Time frame: Through Day 14
Incidence of clinically relevant non-major (CRNM) bleeding
Time frame: Through Day 14
Concentrations of REGN9933 in serum
Time frame: Up to Day 75
Concentrations of REGN7508 in serum
Time frame: Up to Day 75
Change in activated partial thromboplastin time (aPTT)
Time frame: Up to Day 75
Change in prothrombin time (PT)
Time frame: Up to Day 75
Incidence of anti-drug antibody (ADA) to REGN9933 over time
Time frame: Up to Day 75
Magnitude of ADA to REGN9933 over time
Time frame: Up to Day 75
Incidence of ADA to REGN7508 over time
Time frame: Up to Day 75
Magnitude of ADA to REGN7508 over time
Time frame: Up to Day 75
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Related trials for Venous Thromboembolism
RecruitingPhase 3
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RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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RecruitingPhase 4
Aspirin vs. Rivaroxaban for Thromboprophylaxis in Multiple Myeloma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REGN9933 and REGN7508 in people with Venous Thromboembolism, run by Regeneron Pharmaceuticals at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Israel, United States, Canada, United Kingdom, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of confirmed VTE per central reading center (CRC) review (time frame: Through Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.