Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy

Part of paid clinical trials in Tampa, Florida.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06369467
Phase
PHASE1
Status
Recruiting
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Conditions

  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • linvoseltamab — DRUG
    Administered by intravenous (IV) infusion
  • dupilumab — DRUG
    Administered by subcutaneous (SC) injection

Study Details

This study is researching an experimental drug called linvoseltamab combined with another drug called dupilumab. The study is looking at patients who have severe IgE-mediated food allergy. If the patient has an allergy, the body's defense system (immune system) overreacts to an allergen (eg, certain foods like peanuts, milk, shellfish) by making antibodies called IgE. An antibody is a protein that allows the immune system to find and fight off things the body does not recognize (allergens). IgE antibodies are sent out by cells like plasma cells. These antibodies and allergens bind to other cells that send out chemicals, causing an allergic reaction. The aim of the study is to see what side effects happen when linvoseltamab is combined with dupilumab. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * Does linvoseltamab combined with dupilumab affect other types of antibodies in the blood at different times * How much study drug(s) is in the blood at different times

Key Dates

Start date
May 17, 2024
Status verified
Apr 2026
Primary completion
Mar 28, 2028
Completion
Mar 28, 2028

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Severe IgE-mediated food allergy

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From the initial first dose of linvoseltamab through the end of week 30 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida33613-
Emory University - Winship Cancer InstituteAtlantaGeorgia30322-
Massachusetts General HospitalBostonMassachusetts02114-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Tampa, FL

By research site
University of South Florida· Tampa, FLEmory University - Winship Cancer Institute· Atlanta, GAMassachusetts General Hospital· Boston, MAIcahn School of Medicine at Mount Sinai· New York, NYThe Children's Hospital of Philadelphia· Philadelphia, PA

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