At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 555 enrolled
Drug / intervention
AR101 powder provided in capsules & sachets +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
In Brief
A Phase 3 clinical trial evaluating AR101 powder provided in capsules & sachets and Placebo powder provided in capsules & sachets for Peanut Allergy. Completed, enrolled 555 participants across 69 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesCanada, Denmark, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartDec 2015
Primary CompletionDec 2017
Study CompletionJul 2018
TodayJul 2026
First PostedDec 21, 2015
Enrollment StartDec 22, 2015
Primary CompletionDec 21, 2017
Study CompletionJul 2, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.5 years ago
Interventions
AR101 powder provided in capsules & sachetsbiological
Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
Placebo powder provided in capsules & sachetsbiological
Study product formulated to contain only inactive ingredients for use as defined in the protocol