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

ConditionFood Allergy
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Dupilumab

    Drug

    Administered per protocol

Treatment groups

No treatment groups listed

Trial outcomes

This trial has no outcomes listed.

Locations

This trial has no locations.

Sponsors and contacts

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