Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Aimmune Therapeutics, Inc.
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening and not experiencing dose-limiting symptoms to placebo as defined in the protocol
Serum Immunoglobulin E (IgE) to peanut of ≥10 kUA/L and/or a skin prick test (SPT) to peanut ≥8 mm compared to a negative control
Participants/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
Participants 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
You may not be if
History of other chronic disease (other than asthma, Atopic Dermatitis (AD), or allergic rhinitis) requiring therapy (eg, heart disease, diabetes, hypertension) that would represent a risk to participant's health or safety in this study or ability to comply with study protocol
History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock
History of eosinophilic Gastrointestinal (GI) disease
Asthma at time of enrollment with any of the following:
* Forced Expiratory Volume 1 Second (FEV1) \<80% of predicted or ratio of FEV1 to forced vital capacity (FEV1/FVC) \<75% of predicted with or without controller medications
* Inhaled corticosteroids (ICS) dosing of daily fluticasone (or equivalent ICS based on NHLBI dosing chart)
* One hospitalization in the past year for asthma
* Emergency room visit for asthma within 6 months prior to screening
Use of systemic corticosteroids within 2 months prior to screening
Use of other forms of allergen immunotherapy or immunomodulatory therapy within 3 months prior to screening
Use of any agents known or likely to interact with epinephrine (eg, beta-blockers, angiotensin converting enzyme-inhibitors, tri-cyclic antidepressants, or other drugs), within 3 weeks prior to screening
Allergy to oat (placebo in DBPCFC)
Clareo Health | Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
