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 uppdaterad av: 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
1908
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-post: clinicaltrials@regeneron.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Key Inclusion Criteria:
- 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
- Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
- Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
- Weighs at least 40 kg during the screening period
Key Exclusion Criteria:
- Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
- Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
- Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
- Has current or history of known brain tumors or brain metastases
- Has any major cardiovascular event within approximately the past 30 days prior to study administration
- Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
|
Administreras enligt protokollet
|
|
Experimentell: REGN7508
|
Administreras per protokollet
Andra namn:
|
|
Experimentell: Regn9933
|
Administreras per protokollet
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Tidsram: 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
Tidsram: Approximately 6 months
|
Approximately 6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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]
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic DVT
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic non-fatal PE
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of VTE-related death
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental VTE
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
Tidsram: Approximately 6 months
|
Approximately 6 months
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Severity of TEAEs
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN7508
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN9933
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in Prothrombin Time (PT)
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN7508
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of ADA to REGN9933
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN9933
Tidsram: Up to approximately 9 months
|
Up to approximately 9 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
20 augusti 2026
Primärt slutförande (Beräknad)
25 juni 2029
Avslutad studie (Beräknad)
21 september 2029
Studieregistreringsdatum
Först inskickad
6 juli 2026
Först inskickad som uppfyllde QC-kriterierna
6 juli 2026
Första postat (Faktisk)
13 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R7508-DVT-25103
- 2026-525288-42-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Tidsram för IPD-delning
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
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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