Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

Phase 2

• Conditions: Peanut Allergy
• Interventions: Drug: arachid

• Registration Number: NCT02046083
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the interest of a prolonged maintenance therapy

Detailed Description

Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Last Update Submitted: 2014-01-23
• Study First Posted: 2014-01-27
• Last Update Posted: 2014-01-27
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adolescents between 12 and 18 years
• Clinical History of allergic manifestation within one hour of ingestion of peanuts or Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) peanut positive below the threshold of 2 grams
• Bad reaction peanut demonstrated by positive Patch Test (PT ≥ 3 mm above the negative control) and specific IgE f13> 12 IU / mL and / or rAra h2> 5.8 IU / mL
• Previous follow at least 1 year

Exclusion Criteria

• Lack of response during the initial DBPCFCs to the cumulative dose of 2 grams of peanut or instant dose of 1 gram of peanut

• Uncontrolled asthma and / or severe over the previous year

• Atopic dermatitis uncontrolled

• Initial severe anaphylaxis requiring hospitalization in intensive care

• Presence of a major allergy with anaphylaxis at another allergen risk (milk, egg, nuts, or other)

• Home away from a center could support a severe reaction in emergency

• Lack of motivation and understanding of parents and / or child

• Incapacity

  • to establish a daily logbook of clinical monitoring
  • to support severe reaction after eating peanut
  • to follow a regular peanut ingestion protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	arachid	Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance

Primary Outcome Measures

Name	Time	Method
Percentage of patients which tolerate the cumulative dose of 2 grams of peanut at the end of the first phase of 24 weeks between treatment and placebo groups	at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients which tolerate the cumulative dose of 2 grams of peanut during a Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) after 24 weeks without traces eviction diet after the end of maintenance phase	at 24 weeks
Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase	at 24 weeks
Percentage of patients with adverse effects during induction phase	at 24 weeks
Modifications of the immune profile showing a desensitization to peanut	at 24 weeks

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France