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Monoclonal Antibodies

Linvoseltamab + Dupilumab for Food Allergy

Phase 1
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Use of allergen immunotherapy or immunomodulatory therapy within 6 months prior to screening
Recent history of gastrointestinal bleed, inflammatory bowel disease, severe diverticulitis, or gastrointestinal perforation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through week 30
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called linvoseltamab in combination with another drug called dupilumab for patients with IgE-mediated food allergies. The study aims to see how safe and

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from linvoseltamab plus dupilumab may include allergic reactions similar to those experienced with their existing allergies, as well as any new symptoms related to the experimental drug's interaction with their immune system.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had recent severe stomach or intestinal problems.
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I have tested positive for HIV.
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I have a chronic disease that needs treatment, but it's not atopic dermatitis.
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I haven't been hospitalized for an infection or needed IV antibiotics in the last 2 months.
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I have been treated with BCMA-targeted therapy before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through week 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and through week 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Absolute change in the serum concentration of food allergen-specific IgE
Percent change in the serum concentration of food allergen-specific IgE
Time to reach unquantifiable food allergen-specific serum IgE levels

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Severe IgE-mediated food allergyExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2023
Completed Phase 4
~470

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
671 Previous Clinical Trials
386,497 Total Patients Enrolled
1 Trials studying Food Allergy
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
284 Previous Clinical Trials
255,337 Total Patients Enrolled
~4 spots leftby Oct 2025
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