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

Study Purpose

This study is researching an experimental drug called linvoseltamab when combined with another drug called dupilumab. The study is focused on patients who have IgE-mediated food allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergen bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab. The study is looking at several other research questions, including:

  • - What side effects may happen from taking the study drugs.
  • - Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times.
- How much study drug(s) is in the blood at different times

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Clinical history of documented, ongoing, severe IgE-mediated allergy to food (peanut, hazelnut, walnut, cashew, milk, egg/egg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and/or shrimp; documented symptom[s] of anaphylaxis due to exposure) 2. History of physician reported anaphylaxis to food requiring epinephrine administration and/or requiring an emergency visit or inpatient hospitalization. 3. Must be receiving DUPIXENT as standard of care for the treatment of atopic dermatitis (AD) for a minimum of 12 weeks prior to screening, or willing to initiate dupilumab treatment and must agree to remain on dupilumab for the duration of the study treatment period. 4. Participant must be willing to use an epinephrine auto-injector device. 5. Participant must be willing to receive booster and/or re-vaccination(s), including for live (attenuated) vaccinations, based on results of vaccine antibody titers and investigator opinion. 6. Has a body mass index between 18 and 32 kilogram per square metre (kg/m2), inclusive. Key

Exclusion Criteria:

1. Pregnant or breastfeeding women. 2. History of chronic disease (other than AD) requiring therapy (eg, heart disease, diabetes, hypertension) that, in the opinion of the principal investigator, would represent a risk to the participant's health or safety in this study or the participant's ability to comply with the study protocol. Participants on DUPIXENT for conditions other than AD (eg, asthma, eosinophilic esophagitis (EoE), chronic rhinosinusitis with nasal polyps, prurigo nodularis, etc) are excluded. 3. History of progressive multifocal leukoencephalopathy, neurodegenerative condition, central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months prior to Day 1. 4. Recent history (within past 30 days) of a grade 3 or grade 4 gastrointestinal bleed, history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation. 5. History of moderate or severe asthma based on the Global Initiative for Asthma (GINA) guidelines. 6. Pre-bronchodilator forced expiratory volume in the first second (FEV1) <80% of predicted using local reference values. 7. Any prior exposure to a B-cell maturation antigen (BCMA) targeted therapy. 8. Use of systemic corticosteroids within 2 months prior to screening. 9. Use of other forms of allergen immunotherapy (eg, oral, SC, patch, or sublingual) or immunomodulatory therapy (not including corticosteroids) within 6 months prior to screening. 10. Unwilling to discontinue use of antihistamines within 5 days prior to screening and within 5 days prior to skin prick test (SPT) 11. Hypersensitivity to epinephrine and any of the excipients in the epinephrine product. 12. Within the previous 2 months of the screening visit has a history of bacterial, protozoal, viral or parasite infection requiring hospitalization or treatment with IV anti-infectives. 13. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit. NOTE: Other protocol-defined inclusion/exclusion criteria apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06369467
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regeneron Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trial Management
Principal Investigator Affiliation Regeneron Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Arms & Interventions

Arms

Experimental: Severe IgE-mediated food allergy

Interventions

Drug: - linvoseltamab

Administered by intravenous (IV) infusion

Drug: - dupilumab

Administered by subcutaneous (SC) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

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