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NCT02993107 · ClinicalTrials.gov registry record · Phase 3

PALISADE Follow-on Study (ARC004)

A Phase 3 study, sponsored by Aimmune Therapeutics.

Completed
Registry status
Phase 3
Development phase
388
Enrollment target

NCT02993107: Completed Phase 3 study, sponsored by Aimmune Therapeutics.

NCT02993107 is a Phase 3 study that has completed, run by Aimmune Therapeutics. The registered enrollment target is 388 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02993107, a Phase 3 study, has completed, sponsored by Aimmune Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
388 participants
Enrollment target

Study Summary

The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.

Primary Outcome

Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divi

Interventions

  • BIOLOGICAL AR101

Trial Details

FieldValue
Enrollment Target 388 participants
Start Date 2016-12-29
Est. Completion 2019-05-31
Phase Phase 3
Aimmune Therapeutics

10 total trials

What the finished NCT02993107 record still lists

NCT02993107 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which AR101 is the first listed.

NCT02993107 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02993107 about?

NCT02993107 is a clinical study titled "PALISADE Follow-on Study (ARC004)". The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.

What is the current status of trial NCT02993107?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 388 participants. The study started on 2016-12-29. Estimated completion is 2019-05-31.

What interventions are being tested in trial NCT02993107?

The interventions under investigation include: AR101 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02993107?

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

How this trial's enrollment target compares

Where NCT02993107's enrollment target sits among peer trials

388 973rd of 2000 higher than 1,028 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02993107, the US trial registry maintained by the National Library of Medicine. NCT02993107 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.