Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Andrew J Long, PharmD
With
Robert Levin Charitable Fund
Regeneron Pharmaceuticals
Age
4–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 4 to 50 years (inclusive)
Clinical history of allergy to cow's milk or milk-containing foods
Serum IgE to milk of \>4 kUA/L within the last 12 months and/or a SPT to milk ≥6 mm compared to a negative control
Experience clinical reaction at or before 444 mg cumulative protein dose of cow's milk protein on Screening DBPCFC
No clinical reaction observed during the placebo (oat) Screening DBPCFC
Subjects with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study
Use of effective birth control by female participants of childbearing potential
You may not be if
Any previous exposure to dupilumab
Known hypersensitivity to dupilumab or any of its excipients
Known hypersensitivity to epinephrine or any of its excipients
Allergy to oat (placebo in DBPCFC)
History of severe anaphylaxis to cow's milk, defined as neurological compromise or requiring intubation
Recent history of frequent severe, life-threatening episodes of anaphylaxis or anaphylactic shock as defined as 3 or more episodes of anaphylaxis within the past year
Inability to tolerate biological (antibody) therapies
Body weight \<5 kg at the time of screening
History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
History of a mast cell disorder
Established diagnosis of a primary immunodeficiency disorder
Severe asthma or mild or moderate asthma if uncontrolled or difficult to control
Current participation or within the last 4 months in any other interventional study
Use of medication such as beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
Pregnant or breastfeeding women
Clareo Health | Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy
