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Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT (ARC001)

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AR101 powder provided in capsules
Placebo powder provided in capsules
Sponsored by
Aimmune Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Characterized Peanut Allergen, Peanut, OIT, Oral Desensitization, Peanut Allergen, Allergy, Peanut Allergy, Peanut-Allergic Children, Children, Peanut-Allergic Adults

Eligibility Criteria

4 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Children's Hospital
  • UC San Diego
  • Boston Children's Hospital
  • Mount Sinai Medical Center
  • University of North Carolina
  • Cincinnati Children's Hospital Medical Center
  • The Children's Hospital of Philadelphia
  • Children's Medical Center Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AR101 powder provided in capsules

Placebo powder provided in capsules

Arm Description

Study product provided as peanut protein in pull-apart capsules

Placebo formulation in pull-apart capsules containing only inactive ingredients

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline

Full Information

First Posted
November 13, 2013
Last Updated
November 2, 2021
Sponsor
Aimmune Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01987817
Brief Title
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Acronym
ARC001
Official Title
Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 6, 2014 (Actual)
Primary Completion Date
January 7, 2015 (Actual)
Study Completion Date
January 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aimmune Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Characterized Peanut Allergen, Peanut, OIT, Oral Desensitization, Peanut Allergen, Allergy, Peanut Allergy, Peanut-Allergic Children, Children, Peanut-Allergic Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR101 powder provided in capsules
Arm Type
Experimental
Arm Description
Study product provided as peanut protein in pull-apart capsules
Arm Title
Placebo powder provided in capsules
Arm Type
Placebo Comparator
Arm Description
Placebo formulation in pull-apart capsules containing only inactive ingredients
Intervention Type
Biological
Intervention Name(s)
AR101 powder provided in capsules
Intervention Description
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Intervention Type
Biological
Intervention Name(s)
Placebo powder provided in capsules
Intervention Description
Study product formulated to contain only inactive ingredients for use as defined in the protocol
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
6-9 Months
Secondary Outcome Measure Information:
Title
Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC
Description
The change in maximum tolerated dose of peanut protein from baseline (screening) to the Exit Double-Blind, Placebo-Controlled Food Challenge
Time Frame
6-9 months
Title
Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC
Time Frame
6-9 months
Title
Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC
Time Frame
6-9 months
Title
Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC
Time Frame
6-9 months
Title
Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline
Time Frame
Baseline, 6-9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director of Regulatory Affairs
Organizational Affiliation
Aimmune Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34389504
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.
Results Reference
derived

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

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