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Clinical Trials/NCT06631677
NCT06631677AvailableNot Applicable

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

Regeneron Pharmaceuticals0 sitesStarted: October 8, 2024Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Available
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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).

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 Design

Study Type
Expanded Access

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)
  • •NOTE: Other protocol defined inclusion/exclusion criteria apply.

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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