Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
NCT ID: NCT01987817
Last Updated: 2021-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2014-02-06
2015-01-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AR101 powder provided in capsules
Study product provided as peanut protein in pull-apart capsules
AR101 powder provided in capsules
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsules
Placebo formulation in pull-apart capsules containing only inactive ingredients
Placebo powder provided in capsules
Study product formulated to contain only inactive ingredients for use as defined in the protocol
Interventions
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AR101 powder provided in capsules
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsules
Study product formulated to contain only inactive ingredients for use as defined in the protocol
Eligibility Criteria
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Inclusion Criteria
* 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 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
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_CHAIR
Aimmune Therapeutics, Inc.
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, 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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ARC001
Identifier Type: -
Identifier Source: org_study_id