Clinical trial NCT01904604: Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Official title: Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Keywords: Peanut Allergy
Food Allergy
Viaskin peanut patch
Allergen Immunotherapy
Epicutaneous Immunotherapy
Whole peanut extract
Allergenic product
Immediate hypersensitivity
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Consortium of Food Allergy Research
First posted: 2013-07-22
Enrollment: 75
Sex: ALL
Minimum age (years): 4
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.

Detailed description: This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals who are allergic to peanuts from having severe allergic reactions, when accidentally exposed to peanuts. The study also looks at the safety of the treatment and the effects it has on the immune system.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed peanut allergy OR convincing history of peanut allergy
* A skin prick test positive to peanut (wheal diameter ≥3mm greater than the saline control) OR detectable peanut specific Immunoglobulin E (IgE) (ImmunoCAP \>0.35 kUA/L)
* Positive reaction to a cumulative dose of ≤1044 mg peanut protein in the initial qualifying Oral Food Challenge (OFC)
* Use of an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study
* Ability to perform spirometry maneuvers in accordance with the American Thoracic Society (ATS) guidelines (1994). Children ages 4-11 years who have documented inability to adequately perform spirometry may be enrolled if Peak Expiratory Flow (PEF) is \>80% of predicted
* Provide signed informed consent or assent where indicated

Exclusion Criteria:

* History of anaphylaxis to peanut resulting in hypotension, neurological compromise or requiring mechanical ventilation
* Participation in a study using an investigational new drug in the last 30 days
* Participation in any interventional study for the treatment of food allergy in the past 6 months
* Pregnancy or lactation
* Current or known allergy to the Viaskin Peanut/Placebo patch device or excipients
* Current or known allergy to the placebo allergen (oat flour) in oral food challenge (OFC)
* Currently in a build-up phase of any allergen immunotherapy
* Severe or poorly controlled atopic dermatitis or greater than a mild flare of active disease at enrollment
* Forced Expiratory Volume in 1 Second (FEV1) value \<80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (\>500mcg of Fluticasone or equivalent)
* Use of steroid medications in the following manners: history of daily oral steroid dosing for \>1 month during the past year, or burst or steroid course in the past 3 months, or \>1 burst oral steroid course in the past year or use of oral or parenteral steroids for a non-asthma indication within the past 30 days
* Asthma requiring \>1 hospitalization in the past year for asthma or \>1 Emergency Department (ED) visit in the past 6 months for asthma
* Any previous intubation/mechanical ventilation due to allergies or asthma
* Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory or biologic therapy in the past year
* Use of beta-adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers in the past 30 days
* Inability to discontinue antihistamines for skin testing and OFC
* History of alcohol or drug abuse
* History of cardiovascular disease, uncontrolled hypertension, arrhythmias, chronic lung disease, active eosinophilic gastrointestinal disease, or other medical conditions including immunologic disorders or HIV infection which, in the opinion of the investigator, make the subject unsuitable for treatment or at increased risk of anaphylaxis or poor outcome

Primary outcomes:
measure: Percentage of Subjects With a Successful Treatment Response
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Subjects Desensitized to Peanut Protein
timeFrame: Week 130 (Month 30)
measure: Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein
timeFrame: Week 130 (Month 30)
measure: Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
timeFrame: Week 52
measure: Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
timeFrame: Week 52
measure: Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC)
timeFrame: 8 and 20 weeks after the Week 130 (Month 30) OFC
measure: Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months
timeFrame: Week 52 and Month 30 (Week 130)
measure: Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy
timeFrame: Month 30 (Week 130)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill School of Medicine
state: North Carolina
Study officials:
affiliation: University of Arkansas
name: Stacie M. Jones, MD
role: STUDY_CHAIR
References:
citation: Keet CA, Wood RA. Emerging therapies for food allergy. J Clin Invest. 2014 May;124(5):1880-6. doi: 10.1172/JCI72061. Epub 2014 May 1.
citation: Jones SM, Sicherer SH, Burks AW, Leung DY, Lindblad RW, Dawson P, Henning AK, Berin MC, Chiang D, Vickery BP, Pesek RD, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA; Consortium of Food Allergy Research. Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. J Allergy Clin Immunol. 2017 Apr;139(4):1242-1252.e9. doi: 10.1016/j.jaci.2016.08.017. Epub 2016 Oct 26.
citation: Scurlock AM, Burks AW, Sicherer SH, Leung DYM, Kim EH, Henning AK, Dawson P, Lindblad RW, Berin MC, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA, Jones SM; Consortium for Food Allergy Research (CoFAR). Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research. J Allergy Clin Immunol. 2021 Mar;147(3):992-1003.e5. doi: 10.1016/j.jaci.2020.11.027. Epub 2020 Dec 5.
citation: Chiang D, Chen X, Jones SM, Wood RA, Sicherer SH, Burks AW, Leung DYM, Agashe C, Grishin A, Dawson P, Davidson WF, Newman L, Sebra R, Merad M, Sampson HA, Losic B, Berin MC. Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. J Allergy Clin Immunol. 2018 Jun;141(6):2107-2120. doi: 10.1016/j.jaci.2017.11.060. Epub 2018 Jan 31.