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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01987817
First received: November 13, 2013
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

Condition Intervention Phase
Peanut Allergy
Biological: AR101 powder provided in capsules
Biological: Placebo powder provided in capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen Oral Immunotherapy

Resource links provided by NLM:


Further study details as provided by Aimmune Therapeutics, Inc.:

Primary Outcome Measures:
  • The proportion of subjects who tolerate at least 300 mg (443 mg cumulative) of peanut protein with no more than mild symptoms at the exit Double Blind Placebo Controlled Food Challenge (DBPCFC) [ Time Frame: 6-9 Months ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: January 2014
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AR101 powder provided in capsules
Study product provided in pull-apart peanut protein capsules
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 Comparator: Placebo powder provided in capsules
Placebo formulation in pull-apart capsules containing only inactive ingredients
Biological: Placebo powder provided in capsules
Study product formulated to contain only inactive ingredients for use as defined in the protocol

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

Ages Eligible for Study:   4 Years to 26 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 4 through 26 years
  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987817

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
UC San Diego
San Diego, California, United States, 92123
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Aimmune Therapeutics, Inc.
Investigators
Study Chair: Jerome G. Pinkett,, MBA Director, Clinical Operations
  More Information

Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01987817     History of Changes
Other Study ID Numbers: ARC001 
Study First Received: November 13, 2013
Last Updated: June 21, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Aimmune Therapeutics, Inc.:
Characterized Peanut Allergen
Peanut
OIT
Oral Desensitization
Peanut Allergen
Allergy
Peanut Allergy
Peanut-Allergic Children
Children
Peanut-Allergic Adults

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 25, 2016