PEANUT ALLERGY STUDY

Phase 1

• Conditions: Peanut Allergy; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-004941-94-NL
• Lead Sponsor: Aimmune Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-22
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Completion of ARC003
2. Written informed consent and/or assent from subjects/guardians as appropriate
3. Use of effective birth control by female subjects of child-bearing potential
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Early discontinuation from ARC003
2. Meets any longitudinally applicable ARC003 exclusion criteria
3. Failure to tolerate =443 mg cumulative of peanut protein with no or mild symptoms in the ARC003 Exit DBPCFC (Group 2 only)
4. Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified