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Food AllergyPhase 1NCT06369467

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

A Phase 1 study testing linvoseltamab and dupilumab in people with Food Allergy, run by Regeneron Pharmaceuticals at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Food Allergy
What is being tested?
linvoseltamab and dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
5 sitesUnited States
Study dates
17 May 2024to 31 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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
  • NOTE: Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of South Florida

    Tampa, Florida, 33613

Other trials in United States

About this study

Official title: 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 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
Being tested
linvoseltamab, dupilumab
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
Medical subject headings
Food Hypersensitivity, SeSAME syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • linvoseltamabDrug

    Also called REGN5458

    Administered by intravenous (IV) infusion

  • dupilumabDrug

    Also called Dupixent®, REGN668

    Administered by subcutaneous (SC) injection

Study groups in NCT06369467
Study groupRoleWhat they receive
Severe IgE-mediated food allergyExperimentalNot described
Receives: Drug: linvoseltamab; Drug: dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

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

  2. Severity of TEAEs

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

  3. Incidence of Adverse Event of Special Interest (AESIs)

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

  4. Severity of AESIs

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

  5. Incidence of Serious Adverse Events (SAEs)

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

  6. Severity of SAEs

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

Secondary outcomes (16)

  1. Absolute change in the serum concentration of total IgE over time

    Measured: Baseline to the end of week 30

  2. Percent change in the serum concentration of total IgE over time

    Measured: Baseline to the end of week 30

  3. Time to reach unquantifiable total serum IgE concentration

    Measured: Through the end of week 30

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

    Measured: Through the end of week 30

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

    Measured: Through the end of week 30

  6. Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA)

    Measured: Through the end of week 30

  7. Incidence of participants with unquantifiable concentrations of serum total IgE

    Measured: Through the end of week 30

  8. Absolute change in the serum concentration of food allergen-specific IgE

    In participants who tested positive for a measured food allergen-specific IgE at baseline

    Measured: Baseline through the end of week 30

  9. Percent change in the serum concentration of food allergen-specific IgE

    In participants who tested positive for a measured food allergen-specific IgE at baseline

    Measured: Baseline through the end of week 30

  10. Time to reach unquantifiable food allergen-specific serum IgE levels

    In participants who tested positive for a measured food allergen-specific IgE at baseline

    Measured: Through the end of week 30

  11. Incidence of TEAEs

    Measured: Following the combination study treatment period up to approximately 176 weeks

  12. Severity of TEAEs

    Measured: Following the combination study treatment period up to approximately 176 weeks

  13. Incidence of AESIs

    Measured: Following the combination study treatment period up to approximately 176 weeks

  14. Severity of AESIs

    Measured: Following the combination study treatment period up to approximately 176 weeks

  15. Incidence of SAEs

    Measured: Following the combination study treatment period up to approximately 176 weeks

  16. Severity of SAEs

    Measured: Following the combination study treatment period up to approximately 176 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start17 May 2024
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06369467
Sponsor's protocol ID
R5458-668-ALG-2219
Other IDs
2024-511032-27-00
Status last verified
Jun 2026
First submitted
11 Apr 2024
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing linvoseltamab and dupilumab in people with Food Allergy, run by Regeneron Pharmaceuticals at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From the initial first dose of linvoseltamab through the end of week 30). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06369467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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