Linvoseltamab
DrugAdministered by intravenous (IV) infusion
Other names: REGN5458
NCT Number: NCT06369467
This study is researching an experimental drug called linvoseltamab combined with another drug called dupilumab. The study is looking at patients who have severe IgE-mediated food allergy. If the patient has an allergy, the body's defense system (immune system) overreacts to an allergen (eg, certain foods like peanuts, milk, shellfish) by making antibodies called IgE. An antibody is a protein that allows the immune system to find and fight off things the body does not recognize (allergens). IgE antibodies are sent out by cells like plasma cells. These antibodies and allergens bind to other cells that send out chemicals, causing an allergic reaction. The aim of the study is to see what side effects happen when linvoseltamab is combined with dupilumab.
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
This study is active but is not currently recruiting participants.
18 year–50 year
All sexes
Interventional
Phase 1
University of South Florida, Tampa, Florida, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
Administered by intravenous (IV) infusion
Other names: REGN5458
Administered by subcutaneous (SC) injection
Other names: Dupixent®, REGN668
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Time frame: Baseline to the end of week 30
Time frame: Baseline to the end of week 30
Time frame: Through the end of week 30
Time frame: Through the end of week 30
Time frame: Through the end of week 30
Time frame: Through the end of week 30
Time frame: Through the end of week 30
Time frame: Baseline through the end of week 30
In participants who tested positive for a measured food allergen-specific IgE at baseline
Time frame: Baseline through the end of week 30
In participants who tested positive for a measured food allergen-specific IgE at baseline
Time frame: Through the end of week 30
In participants who tested positive for a measured food allergen-specific IgE at baseline
Time frame: Following the combination study treatment period up to approximately 176 weeks
Time frame: Following the combination study treatment period up to approximately 176 weeks
Time frame: Following the combination study treatment period up to approximately 176 weeks
Time frame: Following the combination study treatment period up to approximately 176 weeks
Time frame: Following the combination study treatment period up to approximately 176 weeks
Time frame: Following the combination study treatment period up to approximately 176 weeks
Regeneron Pharmaceuticals
Industry
A Phase 1 Dose-Escalation Study in Adults With Severe IgE-Mediated Food Allergy, to Assess the Safety, Tolerability, and Pharmacodynamic Effects of Short-Term Linvoseltamab Treatment, a BCMAxCD3 Bispecific Antibody to Induce T-Cell Killing of IgE Producing Plasma Cells, on Top of Chronic Dupilumab Treatment, to Prevent the Formation of New IgE Producing Plasma Cells
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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