Expanded Access of Dupilumab in Adults With Severe Immunoglobulin E (EgE)-Mediated Food Allergy Previously Treated With Linvoseltamab

May 12, 2026 updated by: Regeneron Pharmaceuticals

An Open Label, Expanded Access Program of Dupilumab in Adults With Severe IgE-Mediated Food Allergy Who Have Been Previously Treated With Linvoseltamab and Background Dupilumab

This is an expanded access program of dupilumab. The objective of the program is to provide continued dupilumab to adult participants with severe IgE-mediated food allergy who were previously treated with a short course of linvoseltamab and background dupilumab in the parent study R5458-668-ALG-2219 (NCT06369467).

Study Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

Detailed Description

Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Key Inclusion Criteria

  1. Eligible participants for this program consist of adults who have completed the End of Study (EOS) visit in the parent phase 1 study, R5458-668-ALG-2219 (NCT06369467)
  2. Administration of first dose of EAP dupilumab occurs as defined in the protocol

Key Exclusion Criteria

  1. Participants who, during the parent study (R5458-668-ALG-2219 [NCT06369467]), developed a Serious Adverse Event (SAE) and/or Adverse Event (AE) as defined in the protocol
  2. Any temporary discontinuation of study drug dupilumab lasting >2 weeks during the parent study R5458-668-ALG-2219 (NCT06369467)
  3. Greater than 2 weeks since last administration of study drug dupilumab from the parent study R5458-668-ALG-2219 (NCT06369467)

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R668-ALG-2448

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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