Linvoseltamab + Dupilumab for Food Allergy

Recruiting at 5 trial locations

Overseen By Clinical Trials Administrator

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Regeneron Pharmaceuticals

Must be taking: Dupilumab

Must not be taking: Systemic corticosteroids, Allergen immunotherapy

Disqualifiers: Pregnancy, Chronic disease, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 30 weeks

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new experimental drug, linvoseltamab, works in combination with dupilumab (an existing medication) to treat severe food allergies. The goal is to identify potential side effects and understand how these drugs affect the immune system. It targets individuals who have experienced serious allergic reactions, such as anaphylaxis, to foods like peanuts, milk, or shellfish. Participants should already be using dupilumab for conditions like atopic dermatitis or be willing to start using it for their food allergy. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug combination.

Will I have to stop taking my current medications?

The trial requires participants to stop using antihistamines within 5 days before screening and before a skin prick test. Additionally, you cannot use systemic corticosteroids within 2 months before screening or other forms of allergen immunotherapy within 6 months before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier research found dupilumab safe for children and teenagers with peanut allergies. The side effects matched expectations, with no surprises. However, there is a warning about possible severe allergic reactions, such as anaphylaxis, a quick and serious response.

For linvoseltamab, safety information from past studies on other conditions, like multiple myeloma, is available. These studies showed it to be safe and effective, but they involved different patient types. It is important to note that this drug is still being tested for food allergies, so its safety for this specific use is still under evaluation.

Both treatments are in the early testing stages for food allergies, so much remains to be learned about their combined safety. However, the existing data for each drug separately is encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Linvoseltamab and Dupilumab for treating severe IgE-mediated food allergies because these treatments potentially offer new ways to manage this condition. While standard treatments like antihistamines and epinephrine focus on immediate symptom relief, Linvoseltamab targets the underlying immune response by modulating IgE activity, which is a key player in allergic reactions. Dupilumab, on the other hand, blocks specific pathways involved in inflammation, potentially reducing the frequency and severity of allergic reactions over time. This dual approach could provide a more comprehensive and long-lasting solution for individuals with severe food allergies.

What evidence suggests that linvoseltamab combined with dupilumab might be an effective treatment for severe IgE-mediated food allergy?

Research shows that linvoseltamab may help reduce allergic reactions. In studies with cat and birch allergens, it significantly lowered allergy symptoms. Dupilumab decreases the production of IgE antibodies, which trigger allergic reactions. Research has found that dupilumab can reduce IgE levels by about 50% and help people tolerate foods better. In this trial, participants will receive both linvoseltamab and dupilumab to manage food allergies by calming the body's strong response to allergens. ^{2 3 5 6 7}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Adults with severe IgE-mediated food allergies who are already taking or willing to start dupilumab for atopic dermatitis can join. They must have a BMI of 18-32, be able to use an epinephrine auto-injector, and have had serious allergic reactions to specific foods. Participants should agree to potential booster vaccinations during the study.

Inclusion Criteria

Willing to use an epinephrine auto-injector device

Willing to receive booster and/or re-vaccination(s) based on results of vaccine antibody titers and investigator opinion

Body mass index between 18 and 32 kg/m2

Exclusion Criteria

Pre-bronchodilator FEV1 <80% of predicted

Unwilling to discontinue antihistamines within 5 days prior to screening and skin prick test

I have had recent severe stomach or intestinal problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive linvoseltamab in combination with dupilumab to assess safety, tolerability, and pharmacodynamic effects

30 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dupilumab
• Linvoseltamab

Trial Overview The trial is testing linvoseltamab added to ongoing dupilumab treatment in adults with severe food allergies. It aims to assess the safety and tolerability of this combination therapy and its effects on various antibodies and drug levels in the blood over time.

How Is the Trial Designed?

Group I: Severe IgE-mediated food allergy Experimental Treatment 2 Interventions

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Published Research Related to This Trial

In a study of 100 patients with atopic dermatitis, 36% of those treated with dupilumab developed ocular diseases, significantly higher than the 10% in the reference group.

Severe allergic conjunctivitis and blepharitis were notably more common in the dupilumab group, with 30% and 22% of patients affected, respectively, indicating a need for careful monitoring and potential ophthalmologist consultation before starting treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. Barbé, J., Poreaux, C., Remen, T., et al.[2021]

Dupilumab is an effective treatment for type 2 inflammatory diseases like atopic dermatitis, asthma, and nasosinusal polyposis, as it inhibits the IL-4 receptor, blocking the action of key cytokines involved in these conditions.

The drug has a favorable safety profile, with few and reversible side effects, making it a promising option for patients who do not respond well to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dupilumab: beyond atopic dermatitis, off-label use in dermatology]. Russo, G., Laffitte, E.[2023]

In a study of 818 adults with moderate-to-severe atopic dermatitis treated with dupilumab for at least 16 weeks, 12% of patients successfully spaced their doses or withdrew treatment while still maintaining effectiveness.

Key predictors for successful dose spacing or treatment withdrawal included having non-cutaneous atopic manifestations, a prurigo nodularis phenotype, and being older at the start of treatment, suggesting specific patient profiles can benefit from adjusted treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. Chiricozzi, A., Dal Bello, G., Gori, N., et al.[2023]

Dupixent (dupilumab) is set to receive FDA approval for asthma treatment on October 20, expanding its use beyond atopic dermatitis.

Once approved, Dupixent will be part of a group of monoclonal antibodies, including Nucala, Cinqair, and Fasenra, that target type 2 inflammation in severe asthma, highlighting its role in managing this specific asthma phenotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupixent, a New Entrant In the Asthma Lists. Reinke, T.[2019]

Dupilumab treatment for 52 weeks significantly reduced total IgE levels in adults with severe atopic dermatitis, indicating its effectiveness in modulating immune responses associated with the disease.

While there were no overall changes in specific IgE levels against house dust mite extracts, significant reductions were observed in specific IgE levels for several individual molecular allergens, suggesting dupilumab's targeted immunomodulatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab modulates specific IgE mite responses at the molecular level in severe T2-high atopic dermatitis: A real-world experience. González-Pérez, R., Poza-Guedes, P., Mederos-Luis, E., et al.[2022]

Dupilumab is a monoclonal antibody that specifically targets the IL-4Rα subunit of IL-4 and IL-13 receptors, effectively blocking the signaling pathways of these cytokines involved in type 2 inflammation.

Approved in March 2017 for atopic dermatitis, dupilumab offers a targeted treatment option for eczema by reducing the inflammatory response associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-4Rα Inhibitor for Atopic Disease. Chang, HY., Nadeau, KC.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11724241/

Efficacy and Safety of Dupilumab in Children With Peanut ... Dupilumab treatment resulted in around a 50% reduction in total IgE and ps‐IgE. Abbreviations: DBPCFC, double‐blind placebo‐controlled food ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06369467

Study Details | NCT06369467 | Short-Term Linvoseltamab ... 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 ...

3. hsph.harvard.edu hsph.harvard.edu/nadeau-lab/news/food-allergy-news-updates/

Food Allergy News & Updates While omalizumab blocks IgE directly, dupilumab reduces allergic reaction by blocking IgE production by B cells (see figure 4 above). Omalizumab ...

4. pharmacytimes.com pharmacytimes.com/view/dupilumab-associated-with-reduction-of-food-specific-iges-at-12--and-24-month-periods

Dupilumab Associated With Reduction of Food-Specific ... The results suggest that dupilumab can significantly reduce IgE levels and improve food tolerance in patients with comorbid food allergies; ...

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2753673

Efficacy and Safety of Dupilumab in Adolescents With ... Of the 250 individuals with data on specific conditions, 164 had allergic rhinitis (65.6%), 134 had asthma (53.6%), 152 had food allergy (60.8%) ...

6. link.springer.com link.springer.com/article/10.1007/s40257-025-00952-w

The Safety Data of Dupilumab for the Treatment ... The dupilumab label includes a warning for hypersensitivity reactions, including anaphylaxis, serum sickness or serum sickness-like reactions, ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/761055Orig1s040.pdf

761055Orig1s040 | FDA Although the ability of these data to characterize the safety of dupilumab in patients with EoE is limited, since it consists of subjects ...