Clinical trial NCT06299111: 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Venous Thromboembolism
Keywords: Anti-factor XI (FXI) monoclonal antibody
Venous Thromboembolism
Peripherally inserted central catheter
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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. 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
4. History of known thromboembolic disease or thrombophilia
5. Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol
6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
7. 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)

Note: Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of confirmed VTE per central reading center (CRC) review
timeFrame: Through Day 14
measure: Incidence of treatment-emergent adverse event (TEAEs)
timeFrame: Up to Day 100
measure: Severity of TEAEs
timeFrame: Up to Day 100
Secondary outcomes:
measure: Incidence of confirmed PICC associated venous thrombosis per CRC review
timeFrame: Through Day 14
measure: Incidence of major bleeding
timeFrame: Through Day 14
measure: Incidence of clinically relevant non-major (CRNM) bleeding
timeFrame: Through Day 14
measure: Concentrations of REGN9933 in serum
timeFrame: Up to Day 75
measure: Concentrations of REGN7508 in serum
timeFrame: Up to Day 75
measure: Change in activated partial thromboplastin time (aPTT)
timeFrame: Up to Day 75
measure: Change in prothrombin time (PT)
timeFrame: Up to Day 75
measure: Incidence of anti-drug antibody (ADA) to REGN9933 over time
timeFrame: Up to Day 75
measure: Titer of ADA to REGN9933 over time
timeFrame: Up to Day 75
measure: Incidence of ADA to REGN7508 over time
timeFrame: Up to Day 75
measure: Titer of ADA to REGN7508 over time
timeFrame: Up to Day 75
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Sofia
country: Bulgaria
facility: Sveta Sofia Hospital
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health
state: Ontario
city: Beer-Sheba
country: Israel
facility: Soroka University Medical Center
state: HaDarom
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center
city: Netanya
country: Israel
facility: Lanadio Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Cluj-Napoca
country: Romania
facility: Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: