Clinical trial NCT01867671: Peanut Oral Immunotherapy in Children
Official title: Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peanut Hypersensitivity
Keywords: Allergy, Peanut
Peanut allergy
Hypersensitivity
Immunotherapy
Desensitization, Immunologic
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Immune Tolerance Network (ITN)
First posted: 2013-06-04
Enrollment: 146
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.

Detailed description: An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:

* Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.
* Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.
* Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).
* Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).

Eligibility criteria: Inclusion Criteria:

* Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
* Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
* Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
* A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
* Written informed consent from parent/guardian.

Exclusion Criteria:

* History of severe anaphylaxis with hypotension to peanut;
* Documented clinical history of allergy to oat;
* Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
* Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
* Active eosinophilic gastrointestinal disease in the past 2 years;
* Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
* Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
* Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
* Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
* Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
* Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
* Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
* Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
* Use of any investigational drug in 90 days prior to visit -1;
* Plan to use any investigational drug during the study period;
* The presence of any medical condition that the investigator deems incompatible with participation in the trial.

Primary outcomes:
measure: Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
timeFrame: Week 134
Secondary outcomes:
measure: Percentage of Tolerant Participants at Week 160
timeFrame: Week 160
measure: Count of Participants With Transient Desensitization
timeFrame: Week 134, Week 160
measure: Highest Tolerated Cumulative Dose
timeFrame: Week 160
measure: Percentage of Participants That Withdrew From the Study
timeFrame: Initial Dose Escalation through Week 160 (Tolerance Assessment)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences: Arkansas Children's Hospital
state: Arkansas
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel-Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel-Hill
name: Wesley Burks, MD
role: STUDY_CHAIR
affiliation: University of Arkansas
name: Stacie M. Jones, MD
role: STUDY_CHAIR
References: