Clinical trial NCT01987817: Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Official title: Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peanut Allergy
Keywords: Characterized Peanut Allergen
Peanut
OIT
Oral Desensitization
Peanut Allergen
Allergy
Peanut Allergy
Peanut-Allergic Children
Children
Peanut-Allergic Adults
Lead sponsor: Aimmune Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 56
Sex: ALL
Minimum age (years): 4
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

Detailed description: This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.

Eligibility criteria: Key Inclusion Criteria:

* Ages 4 through 26 years, inclusive
* Clinical history of allergy to peanuts or peanut-containing foods
* Serum IgE to peanut \>0.35 kU/L (determined by UniCAP within the past 12 months) and/or a SPT to peanut \>3 mm compared to control
* Experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via PRACTALL guidelines
* Use of birth control by females of child-bearing potential

Key Exclusion Criteria:

* History of Cardiovascular disease
* History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
* History of other chronic disease
* History of eosinophilic gastrointestinal disease
* Severe asthma
* Mild or moderate asthma if uncontrolled
* Use of omalizumab within the past 6 months or current use of other non-traditional forms of allergen immunotherapy
* Use of beta-blockers(oral), angiotensin-converting enzyme (ACE)
* Pregnancy, lactation
* Having the same place of residence as another study subject
* Participation in an interventional clinical trial 30 days prior to randomization

Primary outcomes:
measure: The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC
timeFrame: 6-9 Months
Secondary outcomes:
measure: Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC
timeFrame: 6-9 months
measure: Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
timeFrame: 6-9 months
measure: Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
timeFrame: 6-9 months
measure: Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
timeFrame: 6-9 months
measure: Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
timeFrame: Baseline, 6-9 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
affiliation: Aimmune Therapeutics, Inc.
name: Director of Regulatory Affairs
role: STUDY_CHAIR
References:
citation: Nilsson C, Scurlock AM, Dellon ES, Brostoff JM, Pham T, Ryan R, Brown KR, Adelman DC, Aceves SS. Onset of eosinophilic esophagitis during a clinical trial program of oral immunotherapy for peanut allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4496-4501. doi: 10.1016/j.jaip.2021.07.048. Epub 2021 Aug 11. No abstract available.