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Clinical Trials/NCT01867671
NCT01867671
Completed
Phase 2

Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)

National Institute of Allergy and Infectious Diseases (NIAID)5 sites in 1 country146 target enrollmentStarted: August 13, 2013Last updated:
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ConditionsPeanut Hypersensitivity

Overview

Phase
Phase 2
Status
Completed
Enrollment
146
Locations
5
Primary Endpoint
Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
12 Months to 48 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

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;

Outcomes

Primary Outcomes

Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)

Time Frame: Week 134

Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.\* \*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.

Secondary Outcomes

  • Count of Participants With Transient Desensitization(Week 134, Week 160)
  • Highest Tolerated Cumulative Dose(Week 160)
  • Percentage of Tolerant Participants at Week 160(Week 160)
  • Percentage of Participants That Withdrew From the Study(Initial Dose Escalation through Week 160 (Tolerance Assessment))

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (5)

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