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)

NCT06299111 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: R9933-DVT-23082023-508603-21-00
• Study Type: interventional
• Target: 195
• Locations: 6 countries
• Sites: 23

Brief 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'. 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

Keywords

Anti-factor XI (FXI) monoclonal antibody; Venous Thromboembolism; Peripherally inserted central catheter

Outcome Measures

Primary Outcomes (3)

• Incidence of confirmed VTE per central reading center (CRC) review

  Through Day 14

• Incidence of treatment-emergent adverse event (TEAEs)

  Up to Day 100

• Severity of TEAEs

  Up to Day 100

Secondary Outcomes (11)

• Incidence of confirmed PICC associated venous thrombosis per CRC review

  Through Day 14

• Incidence of major bleeding

  Through Day 14

• Incidence of clinically relevant non-major (CRNM) bleeding

  Through Day 14

• Concentrations of REGN9933 in serum

  Up to Day 75

• Concentrations of REGN7508 in serum

  Up to Day 75

Study Arms (3)

REGN9933

EXPERIMENTAL

Randomized 1:1:1

Drug: REGN9933

REGN7508

EXPERIMENTAL

Randomized 1:1:1

Drug: REGN7508

Placebo

PLACEBO COMPARATOR

Randomized 1:1:1

Drug: Placebo

Interventions

Placebo DRUG

IV single dose administered

Placebo

REGN7508 DRUG

IV single dose administered

REGN7508

REGN9933 DRUG

Intravenous (IV) single dose administered

REGN9933

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (23)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

Sveta Sofia Hospital

Sofia, 1000, Bulgaria

Location

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Lakeridge Health

Oshawa, Ontario, L1G 2B9, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Shaare Zedek Medical Center

Jerusalem, Jerusalem, 9103102, Israel

Location

Soroka University Medical Center

Beersheba, Southern District, 84101, Israel

Location

Hadassah University Medical Center

Jerusalem, 91120, Israel

Location

Lanadio Medical Center

Netanya, 4244916, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Arensia Research Clinic

Bucharest, 011658, Romania

Location

Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca

Cluj-Napoca, 400006, Romania

Location

University hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Cardiff and Vale University Health Board - University Hospital Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: September 20, 2024
• Primary Completion: March 27, 2026
• Study Completion: March 27, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

RO (2); GB (3); US (6); IL (7); CA (4); BU (1)