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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03126227
The ClinicalTrials.gov registry entry for NCT03126227 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 175-participant average among 13 other Peanut Allergy trials with a reported enrollment target (189% higher). The listed sponsor is Aimmune Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.