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Completed

NCT Number: NCT02046083

Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

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

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Key information

Conditions

Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arachid

Drug

Placebo

Other

Placebo

Primary outcomes

  1. 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

    Time frame: at 24 weeks

Secondary outcomes

  1. Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase

    Time frame: at 24 weeks

  2. Percentage of patients with adverse effects during induction phase

    Time frame: at 24 weeks

  3. Modifications of the immune profile showing a desensitization to peanut

    Time frame: at 24 weeks

  4. 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

    Time frame: at 24 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: PITA 3

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Jan 27, 2014
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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