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

NCT01987817 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: ARC001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 8

Brief Summary

This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

Conditions

Peanut Allergy

Keywords

Characterized Peanut Allergen; Peanut; OIT; Oral Desensitization; Peanut Allergen; Allergy; Peanut Allergy; Peanut-Allergic Children; Children; Peanut-Allergic Adults

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC

  The primary endpoint was the percentage of subjects who achieved desensitization, as determined by tolerating at least 300 mg (443 mg cumulative) of peanut protein at the Exit Double Blind Placebo Controlled Food Challenge (DBPCFC) with no more than mild symptoms (i.e., desensitization responders)

  6-9 Months

Secondary Outcomes (5)

• Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC

  6-9 months

• Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC

  6-9 months

• Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC

  6-9 months

• Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC

  6-9 months

• Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline

  Baseline, 6-9 months

Study Arms (2)

AR101 powder provided in capsules

EXPERIMENTAL

Study product provided as peanut protein in pull-apart capsules

Biological: AR101 powder provided in capsules

Placebo powder provided in capsules

PLACEBO COMPARATOR

Placebo formulation in pull-apart capsules containing only inactive ingredients

Biological: Placebo powder provided in capsules

Interventions

AR101 powder provided in capsules BIOLOGICAL

Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol

AR101 powder provided in capsules

Placebo powder provided in capsules BIOLOGICAL

Study product formulated to contain only inactive ingredients for use as defined in the protocol

Placebo powder provided in capsules

Eligibility Criteria

• Age: 4 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 4 through 26 years, inclusive
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aimmune Therapeutics, Inc.: lead

Study Sites (8)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

UC San Diego

San Diego, California, 92123, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 34389504 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Interventions

Capsules

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Aimmune Therapeutics, Inc.

RegulatoryAffairs@aimmune.com

650-409-5164

Study Officials

• Director of Regulatory Affairs

  Aimmune Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: February 6, 2014
• Primary Completion: January 7, 2015
• Study Completion: January 7, 2015
• Last Updated: November 30, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)