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Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
NCT03126227 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aimmune Therapeutics, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03126227 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Colorado, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03126227?
The interventions under investigation include: Placebo (BIOLOGICAL), AR101 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03126227?
This trial is sponsored by Aimmune Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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