Phase 1 Eczema Trial, Not Yet Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have a confirmed food allergy (such as to peanut, hazelnut, walnut, cashew, milk, egg, soy, wheat, sesame, or shellfish/fish) proven by a skin or blood test or food challenge, AND a specific blood level (total IgE ≥ 400 IU/mL) at your screening visit
• You have been diagnosed with chronic rhinosinusitis (long-term sinus problems) AND have a higher-than-normal IgE level on your screening blood test
• You have been diagnosed with allergic rhinitis (hay fever or year-round nasal allergies) AND have a higher-than-normal IgE level on your screening blood test
• You have well-controlled asthma (as defined by 2024 medical guidelines) AND have a higher-than-normal IgE level on your screening blood test
• You have chronic spontaneous urticaria (ongoing hives or swelling with no clear cause) that has been present for at least 6 weeks at some point before screening, AND have a higher-than-normal IgE level on your screening blood test
• You have atopic dermatitis (eczema) that has been present for at least 6 months before your screening visit AND have a higher-than-normal IgE level on your screening blood test
• You are willing and able to use highly effective contraception during the trial

Who may not be able to join:

• Your IgE blood levels are high for a reason other than an allergic condition
• You plan to intentionally eat foods you are allergic to during the study (applies to food allergy participants)
• You are currently receiving any type of allergen immunotherapy (such as allergy shots or sublingual drops)
• Your exposure to allergens at home or work is expected to change significantly during the trial
• Your routine blood test results at screening are outside acceptable ranges (confirm with trial site)
• You are currently taking certain medications that are not allowed, or you are unable to stop taking them before joining
• You are unwilling to receive blood products if needed
• You currently have an active infection
• You have a serious mental illness, dementia, or problems with drug or alcohol use that would make it difficult to give informed consent or participate
• You have a known sensitivity or allergy to intravenous immunoglobulin (IVIg), a type of antibody treatment given by drip
• You have a history of a condition where your immune system does not work properly from birth (primary immunodeficiency)
• You have a history of disease affecting the brain or nervous system
• You have poorly controlled diabetes, chronic kidney disease, chronic lung disease, uncontrolled heart disease, or a history of cancer within the past 5 years
• You have had a severe allergic or anaphylactic reaction to a type of targeted antibody therapy (monoclonal antibody) or to any ingredient in the study drug
• You have had major surgery requiring general anesthesia within the 12 weeks before screening, or you expect to have major surgery during the trial
• You have donated blood or had significant blood loss in the 30 days before your screening visit
• You are considered part of a vulnerable group, for example if you are currently incarcerated
• The trial doctor does not feel you are a suitable candidate for the study for any reason
• You are unable or unwilling to follow the requirements of the trial
• You have a history of a severe allergic or life-threatening anaphylactic reaction related to your underlying allergic condition

Important: Always verify eligibility with the trial site directly before applying.