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.

Additional information:

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)