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

NCT06369467 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: R5458-668-ALG-22192024-511032-27-00
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Food Allergy

Keywords

Severe Immunoglobulin E (IgE)-Mediated Food Allergy; Peanut; Hazelnut; Walnut; Cashew; Milk; Egg/egg white; Soy; Wheat; Sesame; Cod; Salmon; Tuna; Lobster; Crab; Shrimp

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From the initial first dose of linvoseltamab through the end of week 30

• Severity of TEAEs

  From the initial first dose of linvoseltamab through the end of week 30

• Incidence of Adverse Event of Special Interest (AESIs)

  From the initial first dose of linvoseltamab through the end of week 30

• Severity of AESIs

  From the initial first dose of linvoseltamab through the end of week 30

• Incidence of Serious Adverse Events (SAEs)

  From the initial first dose of linvoseltamab through the end of week 30

• Severity of SAEs

  From the initial first dose of linvoseltamab through the end of week 30

Secondary Outcomes (16)

• Absolute change in the serum concentration of total IgE over time

  Baseline to the end of week 30

• Percent change in the serum concentration of total IgE over time

  Baseline to the end of week 30

• Time to reach unquantifiable total serum IgE concentration

  Through the end of week 30

• Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG

  Through the end of week 30

• Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM)

  Through the end of week 30

Study Arms (1)

Severe IgE-mediated food allergy

EXPERIMENTAL

Drug: linvoseltamab; Drug: dupilumab

Interventions

linvoseltamab DRUG

Administered by intravenous (IV) infusion

Also known as: REGN5458

Severe IgE-mediated food allergy

dupilumab DRUG

Administered by subcutaneous (SC) injection

Also known as: Dupixent®, REGN668

Severe IgE-mediated food allergy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• History of physician reported anaphylaxis to food requiring epinephrine administration and/or requiring an emergency visit or inpatient hospitalization
• 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
• 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
• Participant must be willing to use an epinephrine auto-injector device
• 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
• Has a body mass index between 18 and 32 kilogram per square metre (kg/m2), inclusive

You may not qualify if:

• Pregnant or breastfeeding women
• 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
• 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
• 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
• History of moderate or severe asthma based on the Global Initiative for Asthma (GINA) guidelines
• Pre-bronchodilator forced expiratory volume in the first second (FEV1) \<80% of predicted using local reference values
• Any prior exposure to a B-cell maturation antigen (BCMA) targeted therapy
• Use of systemic corticosteroids within 2 months prior to screening
• 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
• Unwilling to discontinue use of antihistamines within 5 days prior to screening and within 5 days prior to skin prick test (SPT)
• Hypersensitivity to epinephrine and any of the excipients in the epinephrine product
• 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
• Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (7)

University of South Florida

Tampa, Florida, 33613, United States

RECRUITING

Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Clinica Universidad de Navarra- Pamplona

Pamplona, Navarre, 31008, Spain

WITHDRAWN

Clinica Universidad de Navarra - Madrid

Madrid, 28027, Spain

WITHDRAWN

MeSH Terms

Conditions

Food Hypersensitivity; SeSAME syndrome

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): March 28, 2028
• Study Completion (Estimated): March 28, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (5); ES (2)