Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers (PITA 3)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Peanut Allergy

Treatments: Drug: arachid

Study type: Interventional

Funder types: Other

Identifiers

NCT02046083

CHU-0177

2013-A00169-36

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

treatment

Experimental group

Description:

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

Treatment:

Drug: arachid

placebo

Placebo Comparator group

Description:

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