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

This study is currently recruiting participants.
Verified March 2014 by Allergen Research Corporation
Sponsor:
Information provided by (Responsible Party):
Allergen Research Corporation
ClinicalTrials.gov Identifier:
NCT01987817
First received: November 13, 2013
Last updated: March 24, 2014
Last verified: March 2014
  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-Allergic Children and Adults
Biological: Characterized Peanut Allergen
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 (CPNA)Oral Immunotherapy (OIT)

Further study details as provided by Allergen Research Corporation:

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 ]
    .


Estimated Enrollment: 55
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peanut Flour
Biological: Peanut Oral Immunotherapy - Peanut Flour This will be used for dose escalation, build-up, and maintenance.
Biological: Characterized Peanut Allergen
Placebo Comparator: Placebo
Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour Similar in appearance and texture to peanut flour

  Eligibility

Ages Eligible for Study:   4 Years to 26 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01987817

Locations
United States, Arkansas
Arkansas Children's Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72202
United States, California
UC San Diego Recruiting
San Diego, California, United States, 92123
Contact: Stephanie Leonard, MD    858-966-5961      
Principal Investigator: Stephanie Leonard, MD         
Sub-Investigator: Susan Laubach, MD         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sara Little       sara.little@childrens.harvard.edu   
Principal Investigator: Rima Rachid, MD         
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Sally Noone, RN    212-241-0336      
Principal Investigator: Julie Wang, MD         
United States, North Carolina
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Lisa Clark    513-636-2733      
Principal Investigator: Amal Ass'ad, MD         
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathy Pinzone    267-426-2263      
Principal Investigator: Jonathan Spergel, MD         
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: John Bird, MD    214-456-8317      
Principal Investigator: John Bird, MD         
Sponsors and Collaborators
Allergen Research Corporation
  More Information

No publications provided

Responsible Party: Allergen Research Corporation
ClinicalTrials.gov Identifier: NCT01987817     History of Changes
Other Study ID Numbers: ARC001
Study First Received: November 13, 2013
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergen Research Corporation:
Characterized Peanut Allergen
Peanut
OIT
Oral Desensitization
Peanut Allergen
Allergy
Peanut Allergy
Peanut-Allergic Children
Children
Peanut-Allergic Adults

ClinicalTrials.gov processed this record on April 17, 2014