Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT

Peanut Allergy Clinical Trial

— ARC001  

Official title:

Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987817
• Other study ID #: ARC001
• Status: Completed
• Phase: Phase 2
• Start date: February 6, 2014
• Est. completion date: January 7, 2015

Study information

• Verified date: November 2021
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 7, 2015
• Est. primary completion date: January 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101 powder provided in capsules
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
• Placebo powder provided in capsules
Study product formulated to contain only inactive ingredients for use as defined in the protocol

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Mount Sinai Medical Center	New York	New York
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UC San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)	6-9 Months
Secondary	Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC	The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge	6-9 months
Secondary	Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC		6-9 months
Secondary	Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC		6-9 months
Secondary	Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC		6-9 months
Secondary	Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline		Baseline, 6-9 months