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

Launched by REGENERON PHARMACEUTICALS · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new experimental drug called linvoseltamab, which is being tested in combination with an existing medication called dupilumab. The focus is on adults who have severe food allergies caused by an overactive immune response, particularly those who have experienced serious allergic reactions, such as anaphylaxis, after eating certain foods like peanuts or milk. The main goal of the study is to determine how safe and well-tolerated linvoseltamab is when used alongside dupilumab.

To participate in the trial, individuals must have a documented history of severe food allergies and have been on dupilumab for at least 12 weeks, or be willing to start this treatment. Participants will need to agree to use an epinephrine auto-injector, which is a device used to treat severe allergic reactions. Throughout the trial, participants will be monitored for side effects and how the treatment affects their allergies. This study is currently recruiting eligible adults between the ages of 18 and 62. If you're interested in learning more or think you might qualify, it’s a good idea to discuss it with your healthcare provider.

Gender

ALL

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