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NCT01987817 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Peanut Allergy, sponsored by Aimmune Therapeutics.

Completed
Registry status
Phase 2
Development phase
56
Enrollment target
8
Study locations

NCT01987817: Completed Phase 2 study of Peanut Allergy, sponsored by Aimmune Therapeutics.

NCT01987817 is a Phase 2 study of Peanut Allergy that has completed, run by Aimmune Therapeutics. The registered enrollment target is 56 participants, below the 210-participant average among 13 other Peanut Allergy trials with a reported enrollment target (73% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01987817, a Phase 2 study of Peanut Allergy, has completed, sponsored by Aimmune Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
56 participants
Enrollment target
8
Study locations

Study 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.

Primary Outcome

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)

Conditions Studied

Interventions

  • BIOLOGICAL AR101 powder provided in capsules
  • BIOLOGICAL Placebo powder provided in capsules

Study Locations (8)

Arkansas

  • Arkansas Children's Hospital - Little Rock

California

  • UC San Diego - San Diego

Massachusetts

  • Boston Children's Hospital - Boston

New York

  • Mount Sinai Medical Center - New York

North Carolina

  • University of North Carolina - Chapel Hill

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Texas

  • Children's Medical Center Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2014-02-06
Est. Completion 2015-01-07
Phase Phase 2
Aimmune Therapeutics

10 total trials

What the finished NCT01987817 record still lists

NCT01987817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 210-participant average among 13 other Peanut Allergy trials with a reported enrollment target (73% lower).

The record links to 1 condition, with Peanut Allergy appearing as the primary indexed condition, and to 2 interventions - of which AR101 powder provided in capsules is the first listed.

NCT01987817 lists 8 locations in 8 states (Arkansas, California, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT01987817 about?

NCT01987817 is a clinical study titled "Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT". This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

What is the current status of trial NCT01987817?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2014-02-06. Estimated completion is 2015-01-07.

What conditions does trial NCT01987817 study?

This clinical trial studies the following conditions: Peanut Allergy.

What interventions are being tested in trial NCT01987817?

The interventions under investigation include: AR101 powder provided in capsules (BIOLOGICAL), Placebo powder provided in capsules (BIOLOGICAL).

Who is sponsoring clinical trial NCT01987817?

This trial is sponsored by Aimmune Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01987817 being conducted?

This trial has 8 study locations across Arkansas, California, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Peanut Allergy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01987817's enrollment target sits among peer trials

56 9th of 13 higher than 5 of 13 other Peanut Allergy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Peanut Allergy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01987817, the US trial registry maintained by the National Library of Medicine. NCT01987817 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.