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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 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.

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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.

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

FieldValue
Enrollment Target 243 participants
Start Date 2017-10-18
Est. Completion 2019-09-20
Phase Phase 3

Sponsor

Aimmune Therapeutics

10 total trials

What the Registry Record Tells You About NCT03337542

The ClinicalTrials.gov registry entry for NCT03337542 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 243 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 196-participant average among 13 other Peanut Allergy trials with a reported enrollment target (24% 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 1 intervention - of which AR101 is the first listed.

NCT03337542 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.