Clinical trial

A Multicenter, Open-Label, Longer-Term Study of AR101 Characterized Oral Desensitization Immunotherapy in Subjects Who Participated in a Prior AR101 Study

NCT03292484

Name

ARC008

Description

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

Trial arms

Trial start

2017-10-11

Estimated PCD

2023-04-27

Trial end

2023-04-27

Status

Completed

Phase

Early phase I

Treatment

AR101

Arms:

Treatment Pathway 1, 2, 3, 4, 5

Size

911

Primary endpoint

Incidence of adverse events including serious adverse events (Safety and Tolerability)

Approximately 10 years

Eligibility criteria

Key Inclusion Criteria: * Prior participation in an Aimmune AR101 clinical study or any future clinical study that identifies ARC008 as a follow-on study option in the protocol * Written informed consent and/or assent from subjects/guardians as appropriate * Use of effective birth control by sexually active female subjects of childbearing potential Key Exclusion Criteria: * Did not complete a minimum of 3 months of AR101 maintenance therapy if the subject was assigned to AR101 in the parent study * Currently receiving or received within 5 years prior to Screening any type of peanut or other food allergen immunotherapy, except AR101 or unless allowed in the parent study, and except during the follow-up observation period in this study * Discontinued early from the parent study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 911, 'type': 'ACTUAL'}}

Updated at

2023-12-14

1 organization

1 product

1 indication

Organization

Aimmune Therapeutics

Product

AR101

Indication

Peanut Allergy