Linvoseltamab + Dupilumab for Food Allergy

Recruiting at 7 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

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the drug Linvoseltamab + Dupilumab for food allergy?

Dupilumab, one of the components of the treatment, is a drug that has been shown to be effective in treating conditions like atopic dermatitis (a type of eczema) and asthma by blocking certain proteins involved in inflammation. It has a favorable safety profile with few reversible side effects, suggesting it may be beneficial in managing other inflammatory conditions. ^{1 2 3 4 5}

How is the drug Linvoseltamab + Dupilumab unique for treating food allergies?

Linvoseltamab + Dupilumab is unique because it combines two monoclonal antibodies, with Dupilumab already known for targeting specific immune pathways involved in type 2 inflammation, which is common in conditions like atopic dermatitis and asthma. This combination could offer a novel approach by potentially modulating immune responses differently than existing treatments for food allergies. ^{1 2 3 4 6}

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Identification of clinical predictors for dupilumab dose spacing in adults with atopic dermatitis: a real-world study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Prevalence of ocular disease during dupilumab treatment for atopic dermatitis: a bicentric retrospective comparative cohort study. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

IL-4Rα Inhibitor for Atopic Disease. [2019]

6. Switzerland 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. [2022]