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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511032-27-00 | Registry Identifier | EU CT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe IgE-mediated food allergy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linvoseltamab | Drug | Administered by intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | From the initial first dose of linvoseltamab through the end of week 30 | |
| Severity of TEAEs | From the initial first dose of linvoseltamab through the end of week 30 | |
| Incidence of Adverse Event of Special Interest (AESIs) | From the initial first dose of linvoseltamab through the end of week 30 | |
| Severity of AESIs | From the initial first dose of linvoseltamab through the end of week 30 | |
| Incidence of Serious Adverse Events (SAEs) | From the initial first dose of linvoseltamab through the end of week 30 | |
| Severity of SAEs | From the initial first dose of linvoseltamab through the end of week 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in the serum concentration of total IgE over time | Baseline to the end of week 30 | |
| Percent change in the serum concentration of total IgE over time | Baseline to the end of week 30 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33613 | United States | ||
| Emory University - Winship Cancer Institute |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| dupilumab | Drug | Administered by subcutaneous (SC) injection |
|
|
| Time to reach unquantifiable total serum IgE concentration | Through the end of week 30 |
| Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG | 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) | 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) | Through the end of week 30 |
| Incidence of participants with unquantifiable concentrations of serum total IgE | 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 | 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 | 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 | Through the end of week 30 |
| Incidence of TEAEs | Following the combination study treatment period up to approximately 176 weeks |
| Severity of TEAEs | Following the combination study treatment period up to approximately 176 weeks |
| Incidence of AESIs | Following the combination study treatment period up to approximately 176 weeks |
| Severity of AESIs | Following the combination study treatment period up to approximately 176 weeks |
| Incidence of SAEs | Following the combination study treatment period up to approximately 176 weeks |
| Severity of SAEs | Following the combination study treatment period up to approximately 176 weeks |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| C557674 | SeSAME syndrome |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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