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Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)

6. juli 2026 opdateret af: Regeneron Pharmaceuticals

A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter [PICC]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism [VTE]) and lead to serious health problems or be life threatening.

The aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drugs
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
  • If the study drugs affect the ability of the blood to clot normally

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1908

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Key Inclusion Criteria:

  1. Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol
  2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
  3. Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
  4. Weighs at least 40 kg during the screening period

Key Exclusion Criteria:

  1. Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
  2. Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
  3. Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
  4. Has current or history of known brain tumors or brain metastases
  5. Has any major cardiovascular event within approximately the past 30 days prior to study administration
  6. Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Administreret i henhold til protokollen
Eksperimentel: REGN7508
Medicin: Regn7508
Administreret pr. Protokol
Andre navne:
  • cenvacibart
Eksperimentel: Regn9933
Medicin: Regn9933
Administreret pr. Protokol
Andre navne:
  • amrecibart

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
Tidsramme: Approximately 6 months
Approximately 6 months

Sekundære resultatmål

Resultatmål
Tidsramme
Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death]
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of symptomatic DVT
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of symptomatic non-fatal PE
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of VTE-related death
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of incidental VTE
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
Tidsramme: Approximately 6 months
Approximately 6 months
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
Tidsramme: Approximately 6 months
Approximately 6 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Severity of TEAEs
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Concentrations of REGN7508
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Concentrations of REGN9933
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Change from baseline in Prothrombin Time (PT)
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Magnitude of ADA to REGN7508
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Occurrence of ADA to REGN9933
Tidsramme: Up to approximately 9 months
Up to approximately 9 months
Magnitude of ADA to REGN9933
Tidsramme: Up to approximately 9 months
Up to approximately 9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Efterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. august 2026

Primær færdiggørelse (Anslået)

25. juni 2029

Studieafslutning (Anslået)

21. september 2029

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R7508-DVT-25103
  • 2026-525288-42-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD-delingstidsramme

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 the study 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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Venøs tromboembolisme (VTE)

Kliniske forsøg med Placebo

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