protocolSection identificationModule nctId: NCT06369467, orgStudyIdInfo id: R5458-668-ALG-2219, secondaryIdInfos id: 2024-511032-27-00, type: REGISTRY, domain: EU CT Number, briefTitle: Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-04-24, completionDateStruct date: 2026-04-24, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: 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, conditionsModule conditions: Food Allergy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: linvoseltamab, interventions name: dupilumab, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Severity of TEAEs, primaryOutcomes measure: Incidence of adverse event of special interest (AESIs), primaryOutcomes measure: Severity of AESIs, primaryOutcomes measure: Incidence of serious adverse events (SAEs), primaryOutcomes measure: Severity of SAEs, secondaryOutcomes measure: Absolute change in the serum concentration of total IgE over time, secondaryOutcomes measure: Percent change in the serum concentration of total IgE over time, secondaryOutcomes measure: Time to reach unquantifiable total serum IgE concentration, secondaryOutcomes measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG, secondaryOutcomes measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM), secondaryOutcomes measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA), secondaryOutcomes measure: Incidence of participants with unquantifiable concentrations of serum total IgE, secondaryOutcomes measure: Absolute change in the serum concentration of food allergen-specific IgE, secondaryOutcomes measure: Percent change in the serum concentration of food allergen-specific IgE, secondaryOutcomes measure: Time to reach unquantifiable food allergen-specific serum IgE levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False