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Peanut Oral Immunotherapy Study of Early Intervention for Desensitization

NCT03736447 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2023-03-02

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to \< 4 years.

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2022-07-05
Completion
2022-07-05
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • 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 NCT03736447 on ClinicalTrials.gov