Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study
NCT ID: NCT02198664
Last Updated: 2021-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2014-08-27
2018-01-04
Brief Summary
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Detailed Description
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* Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001
* Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001
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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARC001 placebo group
Subjects who received placebo in study ARC001.
AR101 - Peanut protein capsule
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
ARC001 AR101 group
Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001.
AR101 - Peanut protein capsule
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Interventions
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AR101 - Peanut protein capsule
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
4 Years
26 Years
ALL
No
Sponsors
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Aimmune Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Director of Regulatory Affairs
Role: STUDY_DIRECTOR
Aimmune Therapeutics
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
UC San Diego
San Diego, California, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mount Sinai Medical Center
New York, New York, United States
University of North Carolina Chapel HIll
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ARC002
Identifier Type: -
Identifier Source: org_study_id