Peanut Oral Immunetherapy
Your child is invited to participate because your child has a peanut allergy. The study will last up to 72 weeks where you will take daily study drug, monthly study injections, complete study questionnaires/diaries, food challenge, skin prick tests, breathing tests, and have your blood drawn.
For Dupilumab there are common risks such as: conjunctivitis (pink eye), injection site reaction (swelling, redness, etc.), your child may experience a local or generalized allergic reaction (also known as a hypersensitivity reaction).
For AR101 Side effects were mostly allergic reactions, ranging from individual symptoms to anaphylaxis, which is a combination of allergic symptoms that ranges from mild to severe.
Common risks seen are diarrhea/Stomach irritation, headache, common cold or infection, fever, sleepiness/fatigue, chest discomfort, EoE (a condition involving the presence of white blood cells called eosinophils and inflammation in the esophagus).
There may or may not be a direct benefit to you as a result of taking part in this study.
Study phase: II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
- 6-17 years old
- Clinical history of allergy to peanuts or peanut-containing foods
- Experience dose-limiting symptoms at or before the 100 mg challenge dose (≤144 mg cumulative) of peanut protein (measured as 200 mg of peanut flour) on screening DBPCFC conducted in accordance with PRACTALL (Practical Issues in Allergology, Joint United States/European Union Initiative) guidelines
- Not experiencing dose-limiting symptoms to placebo.
- Serum IgE to peanut of ≥24 kUA/L and/or a SPT to peanut ≥10 mm compared to a negative control.
- Subjects/caregivers must be trained on the proper use of the epinephrine auto injector device to be allowed to enroll in the study.
- 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.
- Willing and able to comply with all clinic visits and study-related procedures.
Your child’s participation in this study may last up to 72 weeks.
This study consists of:
• A screening period of up to 8 weeks,
• A treatment period of approximately 28 weeks
• A maintenance period of approximately 24 weeks for patients who achieve 300mg/day of AR101 for at least two weeks in the treatment period
• A follow-up period (where we will monitor your child’s health) of approximately 12 weeks after the completion of the study drugs treatment period.
Primary disease category: Allergy & Immunology
Sponsor: Regeneron Pharmaceuticals
Protocol number: R668-ALG-16114
Projected enrollment dates: February 2018 to March 2021
Official study title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)