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NCT03126227 · ClinicalTrials.gov registry record · Phase 3
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
A Phase 3 study of Peanut Allergy, sponsored by Aimmune Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 506
- Enrollment target
- 20
- Study locations
NCT03126227: Completed Phase 3 study of Peanut Allergy, sponsored by Aimmune Therapeutics.
NCT03126227 is a Phase 3 study of Peanut Allergy that has completed, run by Aimmune Therapeutics. The registered enrollment target is 506 participants, above the 175-participant average among 13 other Peanut Allergy trials with a reported enrollment target (189% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03126227, a Phase 3 study of Peanut Allergy, has completed, sponsored by Aimmune Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 506 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
Primary Outcome
Frequency of Treatment Emergent Adverse Events, including Serious Adverse Events, during the overall study period. Treatment-emergent adverse events were defined as adverse events with onset after the first dose of study product.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL AR101
Study Locations (20)
California
- Jonathan Corren, M.D., Inc. - Los Angeles
- Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy - Los Angeles
- Allergy & Asthma Associates of Southern California - 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 - San Diego
- University of California, San Francisco - San Francisco
- Allergy & Asthma Associates of Santa Clara Valley Research Center - San Jose
- UCLA Medical Center, Santa Monica - Santa Monica
- Allergy and Asthma Clinical Research, Inc. - Walnut Creek
Colorado
- Children's Hospital Colorado - Aurora
- Asthma & Allergy Associates, PC - Colorado Springs
- National Jewish Health - Denver
- Colorado Allergy & Asthma Centers - Denver
Arizona
- Medical Research of Arizona - Scottsdale
- Banner University of Arizona Medical Center - Tucson
Alabama
- Clinical Research Center of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
District of Columbia
- Children's National Health System - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2018-09-23 |
| Phase | Phase 3 |
What the finished NCT03126227 record still lists
NCT03126227 is an interventional study that assigns participants to a tested intervention. The registered 506 participants enrollment target is mid-sized for trials with a published cap, above the 175-participant average among 13 other Peanut Allergy trials with a reported enrollment target (189% higher).
The record links to 1 condition, with Peanut Allergy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03126227 names 20 study sites across 6 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT03126227 about?
NCT03126227 is a clinical study titled "Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)". This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101 using the characterized oral desensitization immunotherapy (CODIT™) regimen in peanut-allergic children.
What is the current status of trial NCT03126227?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 506 participants. The study started on 2017-05-08. Estimated completion is 2018-09-23.
What conditions does trial NCT03126227 study?
This clinical trial studies the following conditions: Peanut Allergy.
What interventions are being tested in trial NCT03126227?
The interventions under investigation include: Placebo (BIOLOGICAL), AR101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03126227?
This trial is sponsored by Aimmune Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03126227 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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 NCT03126227's enrollment target sits among peer trials
506 2nd of 13 the highest 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
-
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
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Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)
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Safety Study of Viaskin Peanut to Treat Peanut Allergy
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AR101 Real-World Open-Label Extension Study
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Evaluating the Safety and Efficacy of Oral Encapsulated Microbiota Transplantation Therapy in Peanut Allergic Patients
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