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

Food Allergy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369467
• Other study ID #: R5458-668-ALG-2219
• Secondary ID: 2024-511032-27-0
• Status: Recruiting
• Phase: Phase 1
• Start date: May 6, 2024
• Est. completion date: April 24, 2026

Study information

• Verified date: April 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: April 24, 2026
• Est. primary completion date: April 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Key Inclusion Criteria:

1. 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)

2. History of physician reported anaphylaxis to food requiring epinephrine administration and/or requiring an emergency visit or inpatient hospitalization

3. Must be receiving DUPIXENT as standard of care for the treatment of atopic dermatitis (AD) for a minimum of 12 weeks prior to screening, or willing to initiate dupilumab treatment and must agree to remain on dupilumab for the duration of the study treatment period

4. Participant must be willing to use an epinephrine auto-injector device

5. 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

6. Has a body mass index between 18 and 32 kilogram per square metre (kg/m2), inclusive

Key Exclusion Criteria:

1. Pregnant or breastfeeding women

2. History of chronic disease (other than AD) 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 (eg, asthma, eosinophilic esophagitis (EoE), chronic rhinosinusitis with nasal polyps, prurigo nodularis, etc) are excluded.

3. History of progressive multifocal leukoencephalopathy, neurodegenerative condition, central nervous system (CNS) movement disorder, or patients with a history of seizure within 12 months prior to Day 1

4. 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

5. History of moderate or severe asthma based on the Global Initiative for Asthma (GINA) guidelines

6. Pre-bronchodilator forced expiratory volume in the first second (FEV1) <80% of predicted using local reference values

7. Any prior exposure to a B-cell maturation antigen (BCMA) targeted therapy

8. Use of systemic corticosteroids within 2 months prior to screening

9. Use of other forms of allergen immunotherapy (eg, oral, SC, patch, or sublingual) or immunomodulatory therapy (not including corticosteroids) within 6 months prior to screening

10. Unwilling to discontinue use of antihistamines within 5 days prior to screening and within 5 days prior to skin prick test (SPT)

11. Hypersensitivity to epinephrine and any of the excipients in the epinephrine product

12. 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

13. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit NOTE: Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• linvoseltamab
Administered by intravenous (IV) infusion
• dupilumab
Administered by subcutaneous (SC) injection

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)		Up to Week 30
Primary	Severity of TEAEs		Up to week 30
Primary	Incidence of adverse event of special interest (AESIs)		Up to week 30
Primary	Severity of AESIs		Up to week 30
Primary	Incidence of serious adverse events (SAEs)		Up to week 30
Primary	Severity of SAEs		Up to week 30
Secondary	Absolute change in the serum concentration of total IgE over time		Baseline to week 30
Secondary	Percent change in the serum concentration of total IgE over time		Baseline to week 30
Secondary	Time to reach unquantifiable total serum IgE concentration		Through week 30
Secondary	Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG		Through week 30
Secondary	Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM)		Through week 30
Secondary	Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA)		Through week 30
Secondary	Incidence of participants with unquantifiable concentrations of serum total IgE		Through week 30
Secondary	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	Baseline through week 30
Secondary	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	Baseline through week 30
Secondary	Time to reach unquantifiable food allergen-specific serum IgE levels	In participants who tested positive for a measured food allergen-specific IgE at baseline	Through week 30