Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)

NCT03292484 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 911

Last updated 2024-12-19

Study results available
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Summary

The purpose of this study is to assess AR101's safety, tolerability and efficacy over an extended dosing period.

Conditions

Interventions

BIOLOGICAL

AR101

AR101

Sponsors & Collaborators

  • Aimmune Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jen Garcia · Director, Clinical Operations

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2023-04-27
Completion
2023-04-27
FDA Drug
Yes

Countries

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

Study Locations

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Entities

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 NCT03292484 on ClinicalTrials.gov