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)

Venous Thromboembolism Clinical Trial

— ROXI-CATH  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299111
• Other study ID #: R9933-DVT-2308
• Secondary ID: 2023-508603-21-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 31, 2024
• Est. completion date: June 8, 2026

Study information

• Verified date: February 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 your 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 your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 195
• Est. completion date: June 8, 2026
• Est. primary completion date: June 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. PICC is anticipated to remain in place for at least 14 days

2. Eastern Cooperative Oncology Group (ECOG) Performance Status =2 or equivalent functional status as described in the protocol

3. Body weight =50 kg and =130 kg during the screening period

4. 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

5. Platelet count =100 x 10^9/L during the screening period as described in the protocol

Key Exclusion Criteria:

1. 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

2. History of prior venous thrombosis in the arm in which the PICC is to be placed

3. History of known thromboembolic disease or thrombophilia

4. Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol

5. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol

6. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (eg. Hemophilia A or B, von Willebrand's disease) Note: Other protocol defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• REGN9933
Intravenous (IV) single dose administered
• REGN7508
IV single dose administered
• Placebo
IV single dose administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of confirmed VTE per central reading center (CRC) review		Through Day 14
Primary	Incidence of treatment-emergent adverse event (TEAEs)		Up to Day 100
Primary	Severity of TEAEs		Up to Day 100
Secondary	Incidence of confirmed PICC associated venous thrombosis per CRC review		Through Day 14
Secondary	Incidence of major bleeding		Through Day 14
Secondary	Incidence of clinically relevant non-major (CRNM) bleeding		Through Day 14
Secondary	Concentrations of REGN9933 in serum		Up to Day 75
Secondary	Concentrations of REGN7508 in serum		Up to Day 75
Secondary	Change in activated partial thromboplastin time (aPTT)		Up to Day 75
Secondary	Change in prothrombin time (PT)		Up to Day 75
Secondary	Incidence of anti-drug antibody (ADA) to REGN9933 over time		Up to Day 75
Secondary	Titer of ADA to REGN9933 over time		Up to Day 75
Secondary	Incidence of ADA to REGN7508 over time		Up to Day 75
Secondary	Titer of ADA to REGN7508 over time		Up to Day 75