Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
NCT ID: NCT06369467
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
6 participants
INTERVENTIONAL
2024-05-17
2028-03-28
Brief Summary
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The study is looking at several other research questions, including:
* What side effects may happen from taking the study drugs
* Does linvoseltamab combined with dupilumab affect other types of antibodies in the blood at different times
* How much study drug(s) is in the blood at different times
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Severe IgE-mediated food allergy
linvoseltamab
Administered by intravenous (IV) infusion
dupilumab
Administered by subcutaneous (SC) injection
Interventions
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linvoseltamab
Administered by intravenous (IV) infusion
dupilumab
Administered by subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of physician reported anaphylaxis to food requiring epinephrine administration and/or requiring an emergency visit or inpatient hospitalization
3. Participants with dupilumab-indicated atopic dermatitis (AD) must be receiving DUPIXENT as standard of care for the treatment of AD for a minimum of 12 weeks prior to screening OR Participants with dupilumab-indicated eosinophilic esophagitis (EoE) must be receiving DUPIXENT as standard of care for the treatment of EoE for a minimum of 12 weeks prior to screening OR Must be willing to initiate dupilumab treatment for food allergy
4. Participants initiating dupilumab treatment must agree to remain on dupilumab for the duration of the combination study treatment and safety follow-up periods. Participants who elect to enter the linvoseltamab re-dosing period, must also remain on continuous dupilumab treatment as outlined. Participants on commercial DUPIXENT must agree to remain on their prescribed dose, as described in the protocol, for the duration of the combination study treatment period
5. Participant must be willing to use an epinephrine auto-injector device
6. Participant must be willing to receive booster and/or re-vaccination(s), including for live (attenuated) vaccinations, based on results of vaccine antibody titers and investigator opinion
7. Has a body mass index between 18 and 32 kilogram per square metre (kg/m2), inclusive
Exclusion Criteria
2. History of chronic disease (other than AD or EoE) requiring therapy (eg, heart disease, diabetes, hypertension) that, in the opinion of the principal investigator, would represent a risk to the participant's health or safety in this study or the participant's ability to comply with the study protocol. Participants on DUPIXENT for conditions other than AD or EoE (eg, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, etc) are excluded
3. Known or suspected progressive multifocal leukoencephalopathy (PML), or history of PML, neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure within 12 months prior to Day 1
4. Recent history (within past 30 days) of a grade 3 or grade 4 gastrointestinal bleed, history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation
5. History of moderate or severe asthma based on the Global Initiative for Asthma (GINA) guidelines
6. Pre-bronchodilator forced expiratory volume in the first second (FEV1) \<80% of predicted using local reference values
7. Any prior exposure to a B-cell maturation antigen (BCMA) targeted therapy
8. Use of systemic corticosteroids within 2 months prior to screening
9. Use of other forms of allergen immunotherapy (eg, oral, SC, patch, or sublingual) or immunomodulatory therapy (not including corticosteroids) within 4 months prior to screening
10. Unwilling to discontinue use of antihistamines within 5 days prior to screening and within 5 days prior to skin prick test (SPT)
11. Hypersensitivity to epinephrine and any of the excipients in the epinephrine product
12. Within the previous 2 months of the screening visit has a history of bacterial, protozoal, viral or parasite infection requiring hospitalization or treatment with IV anti-infectives
13. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit
18 Years
50 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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University of South Florida
Tampa, Florida, United States
Emory University- Winship Cancer Institute
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Clinica Universidad de Navarra- Pamplona
Pamplona, , Spain
Countries
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Central Contacts
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Other Identifiers
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2024-511032-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R5458-668-ALG-2219
Identifier Type: -
Identifier Source: org_study_id