Trials / Completed
CompletedNCT02993107
PALISADE Follow-on Study (ARC004)
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 388 (actual)
- Sponsor
- Aimmune Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101 through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed the ARC003 study.
Detailed description
This is an international, multicenter, open-label, 2-arm follow-on study of the safety, tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the ARC003 study. This study will explore alternative dosing regimens during extended maintenance with AR101.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR101 | AR101 powder provided in capsules \& sachets |
Timeline
- Start date
- 2016-12-29
- Primary completion
- 2019-05-31
- Completion
- 2019-05-31
- First posted
- 2016-12-15
- Last updated
- 2022-03-17
- Results posted
- 2021-12-15
Locations
65 sites across 9 countries: United States, Canada, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02993107. Inclusion in this directory is not an endorsement.