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CompletedNCT02046083PITA 3Updated Aug 3, 2026

Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

A Phase 2/3 interventional study of arachid and Placebo in Peanut Allergy, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by University Hospital, Clermont-Ferrand · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2013, registered Jan 2014).
Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Peanut Allergy

Keywords

  • Teenager
  • Peanut
  • OIT (Oral Induction Tolerance)
03

In context

Peanut Hypersensitivity

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    treatment

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

    Drug: arachid

  • Placebo comparator
    placebo

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

    Other: Placebo

Interventions

  • Drugarachid
  • OtherPlacebo

    Placebo

06

What researchers measure

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

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

Publications

  • Fauquert JL, Michaud E, Pereira B, Bernard L, Gourdon-Dubois N, Rouzaire PO, Rochette E, Merlin E, Evrard B; PITA Group. Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build-up phase of a randomized, double-blind, placebo-controlled trial (PITA study). Clin Exp Allergy. 2018 Jul;48(7):862-874. doi: 10.1111/cea.13148. Epub 2018 May 29. PubMed 29665158 ↗
  • Michaud E, Evrard B, Pereira B, Rochette E, Bernard L, Rouzaire PO, Gourdon-Dubois N, Merlin E, Fauquert JL. Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial. Trials. 2015 Apr 29;16:197. doi: 10.1186/s13063-015-0717-y. PubMed 25925398 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02046083
Responsible party
Sponsor
First posted
Jan 27, 2014
Start date
Jul 18, 2013
Primary completion
Nov 18, 2015
Completion
Jan 18, 2018
Last update
Aug 3, 2026

Study contacts

Jean-Luc FAUQUERT
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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