Actively Recruiting
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Led by Regeneron Pharmaceuticals · Updated on 2026-05-05
6
Participants Needed
7
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 50 years
- Documented ongoing severe IgE-mediated allergy to specific foods (e.g., peanut, milk, shellfish) with symptoms of anaphylaxis
- History of physician-reported anaphylaxis to food requiring epinephrine or emergency care
- Receiving dupilumab for atopic dermatitis or eosinophilic esophagitis for at least 12 weeks prior to screening, or willing to start dupilumab for food allergy
- Agree to remain on dupilumab during study treatment and follow-up
- Willing to use an epinephrine auto-injector
- Willing to receive booster or re-vaccinations as advised
- Body mass index between 18 and 32 kg/m2 inclusive
You will not qualify if you...
- Pregnant or breastfeeding women
- Chronic diseases other than atopic dermatitis or eosinophilic esophagitis that pose health risks or affect study compliance
- Use of dupilumab for conditions other than atopic dermatitis or eosinophilic esophagitis
- Known or suspected progressive multifocal leukoencephalopathy, neurodegenerative conditions, CNS movement disorders, or seizures within 12 months before Day 1
- Recent severe gastrointestinal bleeding, inflammatory bowel disease, severe diverticulitis, or prior gastrointestinal perforation
- History of moderate or severe asthma
- Pre-bronchodilator FEV1 less than 80% of predicted
- Prior exposure to BCMA-targeted therapy
- Systemic corticosteroid use within 2 months before screening
- Use of other allergen immunotherapy or immunomodulatory therapy within 4 months before screening
- Unwillingness to stop antihistamines within 5 days before screening and skin prick test
- Hypersensitivity to epinephrine or its excipients
- Recent serious infections requiring hospitalization or IV treatment within 2 months before screening
- Known HIV infection or seropositivity at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of South Florida
Tampa, Florida, United States, 33613
Actively Recruiting
2
Emory University - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Clinica Universidad de Navarra- Pamplona
Pamplona, Navarre, Spain, 31008
Withdrawn
7
Clinica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Withdrawn
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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