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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

20 Sep 2024 → 27 Mar 2026

Decision date (initial)

2024-08-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Regeneron Pharmaceuticals Inc.

External identifiers

EU CT number

2023-508603-21-00

ClinicalTrials.gov

NCT06299111

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Others, Efficacy, Pharmacodynamic

1. Evaluate the efficacy of REGN9933 and REGN7508 individually, each compared to placebo, for prevention of venous thromboembolism (VTE) after peripherally inserted central catheter (PICC) placement.
2. Assess the overall safety and tolerability of REGN9933 and REGN7508 individually.

Secondary objectives 7

1. Evaluate the efficacy of REGN9933 and REGN7508 individually, each compared to placebo, for prevention of PICC-associated venous thrombosis
2. Evaluate the acute bleeding risk of REGN9933 and REGN7508 individually, each compared to placebo
3. Evaluate the pharmacokinetics (PK) of REGN9933 after a single Intravenous (IV) administration
4. Evaluate the PK of REGN7508 after a single IV administration
5. Assess the pharmacodynamic (PD) effects of REGN9933 and REGN7508 individually on intrinsic and extrinsic coagulation pathways
6. Assess the immunogenicity of REGN9933
7. Assess the immunogenicity of REGN7508

Conditions and MedDRA coding

Venous Thromboembolism

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. PICC is clinically indicated for at least 14 days and 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 ≥45 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
6. Other protocol defined inclusion criteria apply.

Exclusion criteria 8

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 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) as described in the protocol.
8. Other protocol defined exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence of confirmed VTE per central reading center (CRC) review
2. Incidence and severity of treatment-emergent adverse events (TEAE)

Secondary endpoints 7

1. Incidence of confirmed PICC-associated venous thrombosis per CRC review
2. Incidence of major bleeding and clinically relevant non-major (CRNM) bleeding
3. Concentrations of REGN9933
4. Concentrations of REGN7508
5. Change in activated partial thromboplastin time (aPTT) and in prothrombin time (PT)
6. Incidence and magnitude of anti-drug antibodies (ADA) to REGN9933 over time
7. Incidence and magnitude of ADA to REGN7508 over time

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 12

Locations

3 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 49 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications