About Food Allergy Research
The incidence of food allergy has dramatically increased in the United States within the last 20 years. Throughout the country, research is being done on what could be causing these food allergies, as well as how we can treat them. At our Food Allergy Center, research is being conducted in both of these areas.
Clinical Trials
Multiple clinical trials are being conducted looking at possible treatments for food allergy to decrease the chance or severity of an allergic reaction when accidentally ingested. Immunotherapy is currently the main focus of research in food allergy clinical trials, which involves exposing the patient to very small amounts of the food that they are allergic to, in hopes that their immune system will stop reacting to it. This therapy is done under close physician supervision using a strict protocol due to the risk of side effects. These treatments are not safe to be tried at home.
Clinical trials at our Food Allergy Center include oral immunotherapy, given by mouth, and epicutaneous immunotherapy, given through a patch on the skin.
We are currently involved in clinical trials for peanut allergy.
Ongoing (Recruitment Closed or By Invitation Only)
PT-01 A phase I/II trial in 3 parts assessing the safety, tolerability, and efficacy of a once-daily peanut sublingual immunotherapy (SLIT) tablet in adults, adolescents, and children with peanut allergy (ALLIANCE)
Principal Investigator: Dr. Stephanie Leonard
This study is looking at whether using a daily investigational tablet containing peanut protein that dissolves under the tongue can decrease the risk of an allergic reaction if your child is accidentally exposed to peanuts. Participants are compensated. Please contact the study coordinator, Beth Kiernan, at ekiernan@rchsd.org for more information.
To be eligible for this study, an individual must be:
- 4 to 17 years of age
- Diagnosed with peanut allergy
- Currently following a strict peanut-free diet
This is not a complete list of eligibility criteria. The study team will review the full entry criteria for this study with you. Eligible individuals will participate in the study for approximately 1 year.
ClinicalTrials.gov Identifier: NCT05440643.
Principal Investigator: Dr. Stephanie Leonard
This study is looking at whether giving an investigational therapeutic probiotic to infants may help to prevent allergic diseases. Participants are compensated. Please contact Beth Kiernan, CRC, at ekiernan@rchsd.org for more information.
ClinicalTrials.gov Identifier: NCT05003804.
Principal Investigator: Dr. Stephanie Leonard
This study is looking at whether using a daily investigational patch in children with peanut allergy can decrease the risk of an allergic reaction if there is accidental exposure to peanuts. Participants are compensated. Please contact the study coordinator, Beth Kiernan, at ekiernan@rchsd.org for more information.
To be eligible for this study, an individual must be:
ClinicalTrials.gov Identifier: NCT05741476.
Completed Studies
A Phase 2 Study to Evaluate the Sensitivity, Specificity and Safety of DBV1605, a Ready to Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow’s Milk Allergy in Children (APTITUDE)
Sponsor: DBV Technologies
ClinicalTrials.gov Identifier: NCT04492683
A Double-Blind, Placebo-Controlled, Randomized Phase III Trial to Assess the Safety And Efficacy of Viaskin® Peanut in Peanut-Allergic Young Children 1-3 Years of Age (EPITOPE Study)
This is a study designed to determine if an investigational skin patch is safe and effective when used as epicutaneous immunotherapy for peanut allergy in young children aged 1-3 years old.
ClinicalTrials.gov Identifier: NCT03211247
A Multicenter, Open-Label, Long-Term Safety Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study (ARC008)
Sponsor: Aimmune Therapeutics
ClinicalTrials.gov Identifier: NCT03292484
Real-World Ar101 Market-Supporting Experience Study in Peanut Allergic Children Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
Sponsor: Aimmune Therapeutics
ClinicalTrials.gov Identifier: NCT03337542
Peanut Allergy Oral Immunotherapy Study of AR101 For Desensitization in Children and Adults (PALISADE) Follow-On Study (ARC004)
Sponsor: Aimmune Therapeutics
ClinicalTrials.gov Identifier: NCT02993107
Open-Label Follow-Up Study of the PEPITES Study to Evaluate the Long-Term Efficacy and Safety of VIASKIN Peanut (PEOPLE Study)
Sponsor: DBV Technologies
ClinicalTrials.gov Identifier: NCT03013517
A Double-Blind, Placebo-Controlled Randomized Trial to Study the VIASKIN Milk Efficacy and Safety for Treating IgE-Mediated Cow’s Milk Allergy in Children (MILES Study)
Sponsor: DBV Technologies
ClinicalTrials.gov Identifier: NCT02223182
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES) (ARC007)
Sponsor: Aimmune Therapeutics
ClinicalTrials.gov Identifier: NCT03126227
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
Sponsor: Aimmune Therapeutics
ClinicalTrials.gov Identifier: NCT02635776
A Double-Blind, Placebo-Controlled, Randomized Phase III Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy with VIASKIN® Peanut in Peanut-Allergic Children (PEPITES Study)
Sponsor: DBV Technologies
ClinicalTrials.gov Identifier: NCT02636699
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety and Follow-On Study (ARC002)
Sponsor: Aimmune Therapeutics
ClinicalTrials.gov Identifier: NCT02198664
Open-label follow-up study of the VIPES study to evaluate long-term efficacy and safety of the VIASKIN Peanut (OLFUS Study)
Sponsor: DBV Technologies
ClinicalTrials.gov Identifier: NCT01955109
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults using Characterized Peanut Allergen (CPNA) Oral Immunotherapy OIT (ARC001)
Sponsor: Aimmune Therapeutics
ClinicalTrials.gov Identifier: NCT01987817
Principal Investigator (Site): A Double-Blind, Placebo-Controlled, Randomized Trial to Study the VIASKIN Peanut’s Efficacy and Safety for Treating Peanut Allergy in Children and Adults (VIPES Study)
Sponsor: DBV Technologies
ClinicalTrials.gov Identifier: NCT01675882
EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children (EPOPEX)
Sponsor: DBV Technologies
ClinicalTrials.gov Identifier: NCT03859700
Using Biologics to Improve Multi Oral Immunotherapy (mOIT) Outcomes (COMBINE Study)
ClinicalTrials.gov Identifier: NCT03679676.