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

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT06631677
Enrollment
Unknown
Registered
2024-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy

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).

Interventions

DRUGDupilumab

Administered per protocol

Sponsors

Regeneron Pharmaceuticals
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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/

Contacts

CONTACTRequests for compassionate use must be initiated by a treating physician. Physicians should contact
compassionateuserequests@regeneron.com844-734-6643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026