Peanut Allergy Study

Phase 1

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

• Registration Number: EUCTR2021-002533-42-Outside-EU/EEA
• Lead Sponsor: Aimmune Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-07
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Completion of study ARC001
• Written informed consent from subject and/or parent/guardian
• Written assent from all subjects as appropriate
• Use of birth control for females of child-bearing potential
• No change in the status of any longitudinally applicable ARC001
inclusion criteria
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Early termination from ARC001
• For former active AR101 (CPNA) treatment subjects from ARC001
(Group 2), failure to tolerate with no or mild symptoms 300 mg of peanut
protein in their ARC001 exit DBPCFC
• Pregnancy or lactation
• For former placebo subjects from ARC001 (Group 1), a lapse in dosing of
more than 10 days from completion of ARC001
• Change in the status of any longitudinally applicable ARC001 exclusion criteria

Study & Design

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