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NCT03337542 · ClinicalTrials.gov registry record · Phase 3
AR101 Real-World Open-Label Extension Study
A Phase 3 study of Peanut Allergy, sponsored by Aimmune Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 243
- Enrollment target
- 20
- Study locations
NCT03337542: Completed Phase 3 study of Peanut Allergy, sponsored by Aimmune Therapeutics.
NCT03337542 is a Phase 3 study of Peanut Allergy that has completed, run by Aimmune Therapeutics. The registered enrollment target is 243 participants, above the 196-participant average among 13 other Peanut Allergy trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03337542, a Phase 3 study of Peanut Allergy, has completed, sponsored by Aimmune Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 243 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
Primary Outcome
Number of participants with treatment-emergent adverse events including serious adverse events during the overall study period (safety and tolerability)
Conditions Studied
Interventions
- BIOLOGICAL AR101
Study Locations (20)
California
- Jonathan Corren, M.D., Inc. - Los Angeles
- Allergy & Asthma Associates of Southern California - Mission Viejo
- Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital - Mountain View
- Peninsula Research Associates - Rolling Hills Estates
- Allergy & Asthma Medical Group and Research Center - San Diego
- Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego - San Diego
- UCSF, Benioff Children's Hospital - Allergy and Immunology - San Francisco
- Allergy & Asthma Associates of Santa Clara Valley Research Center - San Jose
- UCLA Medical Center, Santa Monica - Santa Monica
- Bay Area Allergy - Walnut Creek
Colorado
- Children's Hospital Colorado - Aurora
- Asthma & Allergy Associates - Colorado Springs
- National Jewish Health - Denver
- Colorado Allergy & Asthma Centers, P.C. - 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 Medical Center - Washington D.C.
Florida
- Sher Allergy Specialists - Center for Cough - Largo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2017-10-18 |
| Est. Completion | 2019-09-20 |
| Phase | Phase 3 |
What the finished NCT03337542 record still lists
NCT03337542 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, above the 196-participant average among 13 other Peanut Allergy trials with a reported enrollment target (24% higher).
The record links to 1 condition, with Peanut Allergy appearing as the primary indexed condition, and to 1 intervention - of which AR101 is the first listed.
NCT03337542 names 20 study sites across 7 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT03337542 about?
NCT03337542 is a clinical study titled "AR101 Real-World Open-Label Extension Study". This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.
What is the current status of trial NCT03337542?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 243 participants. The study started on 2017-10-18. Estimated completion is 2019-09-20.
What conditions does trial NCT03337542 study?
This clinical trial studies the following conditions: Peanut Allergy.
What interventions are being tested in trial NCT03337542?
The interventions under investigation include: AR101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03337542?
This trial is sponsored by Aimmune Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03337542 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 NCT03337542's enrollment target sits among peer trials
243 5th of 13 higher than 9 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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