← Back to Search

Monoclonal Antibodies

Severe IgE-mediated food allergy 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 30

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse event of special interest (AESIs)

Incidence of serious adverse events (SAEs)

Incidence of treatment-emergent adverse events (TEAEs)

+3 more

Secondary outcome measures

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

Absolute change in the serum concentration of total IgE over time

Incidence of participants with unquantifiable concentrations of serum total IgE

+7 more

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

2022

Completed Phase 4

~330

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

625 Previous Clinical Trials

381,792 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

265 Previous Clinical Trials

252,334 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria for participation in this investigation?

"Individuals aged between 18 and 50 years with a documented food allergy are eligible to participate in this trial, which aims to recruit a total of 6 participants."

Answered by AI

Is there an age restriction for participation in this clinical trial, specifically regarding individuals above 70 years old?

"This study is seeking individuals over the age of 18 but under 50 years old to enroll in the trial."

Answered by AI

What is the total number of individuals who are currently enrolled as participants in this medical study?

"Affirmative. Details on clinicaltrials.gov specify that this trial is actively seeking candidates for participation. The study was first listed on May 6, 2024, and underwent its most recent update on April 27, 2024. Recruitment aims to enroll six individuals at a singular designated site."

Answered by AI

Is the current clinical trial open for new participant enrollment?

"Indeed, the details provided on clinicaltrials.gov indicate that this investigation is actively pursuing candidates. The trial was first listed on May 6th, 2024, and recently revised on April 27th of the same year. Researchers aim to recruit a total of 6 participants from one designated site."

Answered by AI

What is the level of risk associated with Severe IgE-mediated food allergy in individuals?

"As part of a Phase 1 clinical trial, Severe IgE-mediated food allergy is rated as 1 for safety based on preliminary data that offers limited support for its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06369467.

All > Penicillin Allergy > Food Allergy