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

NCT06631677 | Unknown

• 1 other identifier: R668-ALG-2448
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Food Allergy

Interventions

Dupilumab DRUG

Administered per protocol

Also known as: REGN668, DUPIXENT®, SAR231893

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Administration of first dose of EAP dupilumab occurs as defined in the protocol

You may not qualify if:

• 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
• Any temporary discontinuation of study drug dupilumab lasting \>2 weeks during the parent study R5458-668-ALG-2219 (NCT06369467)
• Greater than 2 weeks since last administration of study drug dupilumab from the parent study R5458-668-ALG-2219 (NCT06369467)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 8, 2024
• Last Updated: May 14, 2026

Record last verified: 2026-05