A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A

Part of paid clinical trials in Orange, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07416604
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hemophilia A

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NXT007 — COMBINATION_PRODUCT
    NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.
  • Emicizumab — DRUG
    Emicizumab will be administered subcutaneously (SC) using vial and syringe.

Study Details

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.

Key Dates

Start date
Apr 27, 2026
Status verified
Jun 2026
Primary completion
Feb 29, 2028
Completion
Jan 29, 2032

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Main Study Treatment Period: NXT007 Prophylaxis
    Participants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period.
  • Active Comparator: Main Study Treatment Period: Emicizumab Prophylaxis
    Participants randomized to this arm will receive emicizumab prophylaxis for the main study treatment period at 3 mg/kg once weekly (QW) for 4 weeks as loading doses, followed by maintenance dosing of either 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W). Loading doses are not required for participants who were taking emicizumab prior to study start.
  • Experimental: Open-Label Extension Period: NXT007 Prophylaxis
    After the main study treatment period, participants in the NXT007 arm will be able to continue with NXT007 dosing, and participants in the Emicizumab arm will be able to switch to NXT007, in the open-label extension period.

Primary Outcome Measure

Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period [ Time Frame: From Month 2 until the clinical cutoff date (at least 7 months of study treatment) ]

Central Contacts

  • Reference Study ID Number: BO45887 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (3)

FacilityCityStateZIPSite coordinators
Center for Inherited Blood DisordersOrangeCalifornia92868-
Innovative Hematology, Inc.IndianapolisIndiana46260-
Washington Center for Bleeding DisordersSeattleWashington98101-3932-

Find similar trials in Orange, CA

By research site
Center for Inherited Blood Disorders· Orange, CAInnovative Hematology, Inc.· Indianapolis, INWashington Center for Bleeding Disorders· Seattle, WA

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