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ARTEMIS Peanut Allergy In Children

NCT03201003 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2021-08-03

Study results available
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Summary

The purpose of this study is to demonstrate the efficacy and safety of AR101 through oral immunotherapy (OIT) in peanut-allergic children.

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

OTHER

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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2019-02-15
Completion
2019-02-15
FDA Drug
Yes

Countries

  • France
  • Germany
  • Ireland
  • Italy
  • 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 NCT03201003 on ClinicalTrials.gov