Peanut allergy oral immunotherapy study of AR101 for desensitization in children and adults (Palisade) follow-on study.

Phase 3

Completed

• Conditions: peanut allergy; 10001708

• Registration Number: NL-OMON48551
• Lead Sponsor: Aimmune Therapeutics UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the frequency of treatment-related AEs, including SAEs,<br /><br>during the overall study period (from enrollment to the end of EM period).</p><br>