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Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

NCT02198664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-11-09

Study results available
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Summary

This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

Conditions

Interventions

BIOLOGICAL

AR101 - Peanut protein capsule

Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Sponsors & Collaborators

  • Aimmune Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Director of Regulatory Affairs · Aimmune Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-27
Primary Completion
2018-01-04
Completion
2018-01-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02198664 on ClinicalTrials.gov