Expanded Access Program of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Who Have Been Previously Treated With Linvoseltamab and Background Dupilumab in the Parent Study R5458-668-ALG-2219 (NCT06369467)
- Conditions
- Food Allergy
- Registration Number
- NCT06631677
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
This is an expanded access program of dupilumab that was never initiated and, therefore, not available.
- Detailed Description
Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Completion of the end of study (EOS) visit in the prior phase 1 clinical trial, R5458-668-ALG-2219 (NCT04776694)
- Administration of first dose of expanded access program (EAP) dupilumab occurs 2 weeks after the last dose of dupilumab received as part of the R5458-668-ALG-2219 parent study
- Willing and able to use an epinephrine autoinjector device
- Continued avoidance of known food allergens throughout the duration of the EAP
Key
Exclusion Criteria
- Patients who, during the parent study (R5458-668-ALG-2219), developed an SAE and/or AE deemed related to program drug and which led to discontinuation of investigational product
- Any temporary discontinuation of study drug dupilumab lasting >2 weeks during the parent study R5458-668-ALG-2219
- Greater than 2 weeks since last administration of study drug dupilumab from the parent study R5458-668-ALG-2219
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method