Trials / Completed
CompletedNCT02635776
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 555 (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 efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.
Detailed description
This is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AR101 powder provided in capsules & sachets | Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol |
| BIOLOGICAL | Placebo powder provided in capsules & sachets | Study product formulated to contain only inactive ingredients for use as defined in the protocol |
Timeline
- Start date
- 2015-12-22
- Primary completion
- 2017-12-21
- Completion
- 2018-07-02
- First posted
- 2015-12-21
- Last updated
- 2022-03-17
- Results posted
- 2022-03-17
Locations
69 sites across 10 countries: United States, Canada, Denmark, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02635776. Inclusion in this directory is not an endorsement.