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Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using (CPNA) Peanut OIT Safety Follow-On Study

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ClinicalTrials.gov Identifier: NCT02198664
Recruitment Status : Active, not recruiting
First Posted : July 24, 2014
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Aimmune Therapeutics, Inc.

Brief Summary:
This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

Condition or disease Intervention/treatment Phase
Peanut Allergy Biological: Peanut protein capsule Phase 2

Detailed Description:

All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA).

Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study
Study Start Date : August 2014
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Peanut Protein Capsule
Biological: Capsules containing peanut flour, oral immunotherapy, will be used for dose escalation build-up, and maintenance phase
Biological: Peanut protein capsule
characterized peanut allergen provided in break apart capsules for oral immunotherapy



Primary Outcome Measures :
  1. The incidence of treatment-related adverse events and dosing symptoms occurring with peanut OIT over a protracted treatment period comprising at least 18 months [ Time Frame: Up to 90 weeks ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Completion of ARC001 study
  • Use of birth control for females of child-bearing age
  • No change in the status of any longitudinally applicable ARC001 inclusion criteria

Exclusion Criteria:

  • Early termination from ARC001
  • Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge
  • A lapse in dosing of more than 10 days from completion of ARC001
  • Change in the status of any longitudinally applicable ARC001 exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198664


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
Chapel Hill, North Carolina, United States, 25799
United States, Ohio
Cincinnati Chidlren'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 Director: Jerome G. Pinkett, MBA Aimmune Therapeutics

Responsible Party: Aimmune Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02198664     History of Changes
Other Study ID Numbers: ARC002
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

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

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