Food AllergyNCT06631677
Expanded Access of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Previously Treated With Linvoseltamab
A study testing Dupilumab in people with Food Allergy, run by Regeneron Pharmaceuticals.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Allergy
- What is being tested?
- Dupilumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Requests for compassionate use must be initiated by a treating physician. Physicians should contact contact
About this study
Official title: 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
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
- Being tested
- Dupilumab
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called REGN668, DUPIXENT®, SAR231893
Administered per protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631677
- Sponsor's protocol ID
- R668-ALG-2448
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06631677
- Acronym / sponsor ID
- R668-ALG-2448
- Conditions
- Food Allergy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: REGN668, DUPIXENT®, SAR231893Administered per protocol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Requests for compassionate use must be initiated by a treating physician. Physicians should contact contact
Questions about this trial
What is this clinical trial studying?
A study testing Dupilumab in people with Food Allergy, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Requests for compassionate use must be initiated by a treating physician. Physicians should contact (844-734-6643, compassionateuserequests@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.