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Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

NCT02635776 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2022-03-17

Study results available
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Summary

The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

Conditions

Interventions

BIOLOGICAL

AR101 powder provided in capsules & sachets

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

BIOLOGICAL

Placebo powder provided in capsules & sachets

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

Sponsors & Collaborators

  • Aimmune Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Director of Regulatory Affairs · Aimmune Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-22
Primary Completion
2017-12-21
Completion
2018-07-02
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635776 on ClinicalTrials.gov