Peanut AllergyPhase 2/3PITA 3NCT02046083
Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
A Phase 2/3 study testing arachid in people with Peanut Allergy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- arachid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2013to 18 Jan 2018
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Peanut Allergy
- Being tested
- arachid, Placebo
- Keywords
- Teenager, Peanut, OIT (Oral Induction Tolerance)
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arachidDrug
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance Receives: Drug: arachid |
| placebo | Placebo comparator | Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 24 weeks
Secondary outcomes (4)
Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase
Measured: at 24 weeks
Percentage of patients with adverse effects during induction phase
Measured: at 24 weeks
Modifications of the immune profile showing a desensitization to peanut
Measured: at 24 weeks
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
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study start18 Jul 2013
- Primary completion18 Nov 2015
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc FAUQUERT, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046083
- Sponsor's protocol ID
- CHU-0177
- Other IDs
- 2013-A00169-36
- Acronym
- PITA 3
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2014
- Last updated
- 3 Aug 2026
- Results posted
- No
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 29665158Michaud 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