Combining linvoseltamab with dupilumab for severe food allergies

A Phase 1 Dose-Escalation Study in Adults With Severe IgE-Mediated Food Allergy, to Assess the Safety, Tolerability, and Pharmacodynamic Effects of Short-Term Linvoseltamab Treatment, a BCMAxCD3 Bispecific Antibody to Induce T-Cell Killing of IgE Producing Plasma Cells, on Top of Chronic Dupilumab Treatment, to Prevent the Formation of New IgE Producing Plasma Cells

This study is testing whether combining a new drug called linvoseltamab with dupilumab can help adults with severe food allergies feel better and manage their condition more effectively.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Regeneron Pharmaceuticals (Industry-sponsored)
• Drugs / interventions: dupilumab, linvoseltamab, immunotherapy
• Locations: 7 sites (Tampa, Florida and 6 other locations)
• Trial ID: NCT06369467 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of an experimental drug called linvoseltamab when used alongside dupilumab in adults suffering from severe IgE-mediated food allergies. The research focuses on understanding the side effects of this combination treatment and its impact on various antibody levels in the blood. Participants must have a documented history of severe food allergies and be on dupilumab for at least 12 weeks prior to joining the study. The goal is to evaluate the safety and efficacy of this new treatment approach for managing food allergies.

Who should consider this trial

Good fit: Ideal candidates are adults with a documented history of severe IgE-mediated food allergies who are currently receiving dupilumab.

Not a fit: Patients without a history of severe food allergies or those not currently on dupilumab may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with severe food allergies, potentially reducing allergic reactions.

How similar studies have performed: While the combination of these specific drugs is novel, similar approaches in treating allergies have shown promise in other studies.

Eligibility 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. Participants with dupilumab-indicated atopic dermatitis (AD) must be receiving DUPIXENT as standard of care for the treatment of AD for a minimum of 12 weeks prior to screening OR Participants with dupilumab-indicated eosinophilic esophagitis (EoE) must be receiving DUPIXENT as standard of care for the treatment of EoE for a minimum of 12 weeks prior to screening OR Must be willing to initiate dupilumab treatment for food allergy
4. Participants initiating dupilumab treatment must agree to remain on dupilumab for the duration of the combination study treatment and safety follow-up periods. Participants who elect to enter the linvoseltamab re-dosing period, must also remain on continuous dupilumab treatment as outlined. Participants on commercial DUPIXENT must agree to remain on their prescribed dose, as described in the protocol, for the duration of the combination study treatment period
5. Participant must be willing to use an epinephrine auto-injector device
6. 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
7. 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 or EoE) 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 or EoE (eg, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, etc) are excluded
3. Known or suspected progressive multifocal leukoencephalopathy (PML), or history of PML, neurodegenerative condition, central nervous system (CNS) movement disorder, or 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 4 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

Where this trial is running

Tampa, Florida and 6 other locations

• University of South Florida — Tampa, Florida, United States (Recruiting)
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
• Clinica Universidad de Navarra- Pamplona — Pamplona, Navarre, Spain (Withdrawn)
• Clinica Universidad de Navarra - Madrid — Madrid, Spain (Withdrawn)

Study contacts

• Study coordinator: Clinical Trials Administrator

Conditions Food Allergy; Severe Immunoglobulin E-Mediated Food Allergy; Peanut; Hazelnut; Walnut; Cashew; Milk; Egg/egg white