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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Administered by intravenous (IV) infusion
Administered by subcutaneous (SC) injection
University of South Florida
Tampa, Florida, United States
RECRUITINGEmory University- Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGThe Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGClinica Universidad de Navarra - Madrid
Madrid, Spain
WITHDRAWNClinica Universidad de Navarra- Pamplona
Pamplona, Spain
WITHDRAWNIncidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Severity of TEAEs
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Incidence of Adverse Event of Special Interest (AESIs)
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Severity of AESIs
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Incidence of Serious Adverse Events (SAEs)
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Severity of SAEs
Time frame: From the initial first dose of linvoseltamab through the end of week 30
Absolute change in the serum concentration of total IgE over time
Time frame: Baseline to the end of week 30
Percent change in the serum concentration of total IgE over time
Time frame: Baseline to the end of week 30
Time to reach unquantifiable total serum IgE concentration
Time frame: Through the end of week 30
Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG
Time frame: Through the end of week 30
Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM)
Time frame: Through the end of week 30
Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA)
Time frame: Through the end of week 30
Incidence of participants with unquantifiable concentrations of serum total IgE
Time frame: Through the end of week 30
Absolute change in the serum concentration of food allergen-specific IgE
In participants who tested positive for a measured food allergen-specific IgE at baseline
Time frame: Baseline through the end of week 30
Percent change in the serum concentration of food allergen-specific IgE
In participants who tested positive for a measured food allergen-specific IgE at baseline
Time frame: Baseline through the end of week 30
Time to reach unquantifiable food allergen-specific serum IgE levels
In participants who tested positive for a measured food allergen-specific IgE at baseline
Time frame: Through the end of week 30
Incidence of TEAEs
Time frame: Following the combination study treatment period up to approximately 176 weeks
Severity of TEAEs
Time frame: Following the combination study treatment period up to approximately 176 weeks
Incidence of AESIs
Time frame: Following the combination study treatment period up to approximately 176 weeks
Severity of AESIs
Time frame: Following the combination study treatment period up to approximately 176 weeks
Incidence of SAEs
Time frame: Following the combination study treatment period up to approximately 176 weeks
Severity of SAEs
Time frame: Following the combination study treatment period up to approximately 176 weeks
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