Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Iā¦ (NCT06369467) | Clinical Trial Compass
RecruitingPhase 1
Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy
United States6 participantsStarted 2024-05-17
Plain-language summary
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
Who can participate
Age range18 Years ā 50 Years
SexALL
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Inclusion criteria
ā. Clinical history of documented, ongoing, severe IgE-mediated allergy to food (peanut, hazelnut, walnut, cashew, milk, egg/egg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and/or shrimp; documented symptom\[s\] of anaphylaxis due to exposure)
ā. History of physician reported anaphylaxis to food requiring epinephrine administration and/or requiring an emergency visit or inpatient hospitalization
ā. 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
ā. 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
ā. Participant must be willing to use an epinephrine auto-injector device
ā. 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
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From the initial first dose of linvoseltamab through the end of week 30
2
Severity of TEAEs
Timeframe: From the initial first dose of linvoseltamab through the end of week 30
3
Incidence of Adverse Event of Special Interest (AESIs)
Timeframe: From the initial first dose of linvoseltamab through the end of week 30
4
Severity of AESIs
Timeframe: From the initial first dose of linvoseltamab through the end of week 30
5
Incidence of Serious Adverse Events (SAEs)
Timeframe: From the initial first dose of linvoseltamab through the end of week 30
6
Severity of SAEs
Timeframe: From the initial first dose of linvoseltamab through the end of week 30
ā. Has a body mass index between 18 and 32 kilogram per square metre (kg/m2), inclusive
Exclusion criteria
ā. Pregnant or breastfeeding women
ā. 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
ā. 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
ā. 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
ā. History of moderate or severe asthma based on the Global Initiative for Asthma (GINA) guidelines
ā. Pre-bronchodilator forced expiratory volume in the first second (FEV1) \<80% of predicted using local reference values
ā. Any prior exposure to a B-cell maturation antigen (BCMA) targeted therapy
ā. Use of systemic corticosteroids within 2 months prior to screening