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NCT02635776 · ClinicalTrials.gov registry record · Phase 3
Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
A Phase 3 study of Peanut Allergy, sponsored by Aimmune Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 555
- Enrollment target
- 20
- Study locations
NCT02635776: Completed Phase 3 study of Peanut Allergy, sponsored by Aimmune Therapeutics.
NCT02635776 is a Phase 3 study of Peanut Allergy that has completed, run by Aimmune Therapeutics. The registered enrollment target is 555 participants, above the 172-participant average among 13 other Peanut Allergy trials with a reported enrollment target (223% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02635776, a Phase 3 study of Peanut Allergy, has completed, sponsored by Aimmune Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 555 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The percentage of subjects in the ITT population who achieve desensitization as determined by tolerating specified challenge doses of peanut protein with no more than mild symptoms at the Exit Oral Food Challenge.
Conditions Studied
Interventions
- BIOLOGICAL AR101 powder provided in capsules & sachets
- BIOLOGICAL Placebo powder provided in capsules & sachets
Study Locations (20)
California
- Long Beach Memorial Medical Center / Miller Children's and Women's Hospital - Long Beach
- UCLA Medical Center, Santa Monica - Los Angeles
- Allergy & Asthma Associates of Southern California dba Southern California Research - Mission Viejo
- Sean N. Parker Center for Allergy Research, LPCH at El Camino Hospital - Mountain View
- Peninsula Research Associates, Inc. - Rolling Hills Estates
- Allergy & Asthma Medical Group and Research Center, A.P.C - San Diego
- Rady Children's Hospital - San Diego
- University of California, San Francisco - San Francisco
Colorado
- Children's Hospital Colorado - Aurora
- Colorado Allergy & Asthma Centers, P.C. - Centennial
- National Jewish Health - Denver
Florida
- Windom Allergy, Asthma and Sinus - Sarasota
- University of South Florida Asthma, Allergy & Immunology Clinical Research Unit - Tampa
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- Comer Children's Hospital - Chicago
Arizona
- Banner University of Arizona Medical Center - Tucson
Arkansas
- Arkansas Children's Hospital - Little Rock
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Atlanta Allergy & Asthma Clinic, PA - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2015-12-22 |
| Est. Completion | 2018-07-02 |
| Phase | Phase 3 |
What the finished NCT02635776 record still lists
NCT02635776 is an interventional study that assigns participants to a tested intervention. The registered 555 participants enrollment target is mid-sized for trials with a published cap, above the 172-participant average among 13 other Peanut Allergy trials with a reported enrollment target (223% higher).
The record links to 1 condition, with Peanut Allergy appearing as the primary indexed condition, and to 2 interventions - of which AR101 powder provided in capsules & sachets is the first listed.
NCT02635776 names 20 study sites across 9 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT02635776 about?
NCT02635776 is a clinical study titled "Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)". 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.
What is the current status of trial NCT02635776?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2015-12-22. Estimated completion is 2018-07-02.
What conditions does trial NCT02635776 study?
This clinical trial studies the following conditions: Peanut Allergy.
What interventions are being tested in trial NCT02635776?
The interventions under investigation include: AR101 powder provided in capsules & sachets (BIOLOGICAL), Placebo powder provided in capsules & sachets (BIOLOGICAL).
Who is sponsoring clinical trial NCT02635776?
This trial is sponsored by Aimmune Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02635776 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Peanut Allergy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02635776's enrollment target sits among peer trials
555 1st of 13 higher than 13 of 13 other Peanut Allergy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peanut Allergy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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