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COMPLETED Phase 3

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

NCT02635776 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

Conditions Studied

Interventions

  • BIOLOGICAL AR101 powder provided in capsules & sachets
  • BIOLOGICAL Placebo powder provided in capsules & sachets

Study Locations (20)

California

  • Long Beach Memorial Medical Center / Miller Children's and Women's Hospital — Long Beach
  • UCLA Medical Center, Santa Monica — Los Angeles
  • Allergy & Asthma Associates of Southern California dba Southern California Research — 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
  • University of California, San Francisco — San Francisco

Colorado

  • Children's Hospital Colorado — Aurora
  • Colorado Allergy & Asthma Centers, P.C. — Centennial
  • National Jewish Health — Denver

Florida

  • Windom Allergy, Asthma and Sinus — Sarasota
  • University of South Florida Asthma, Allergy & Immunology Clinical Research Unit — Tampa

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
  • Comer Children's Hospital — Chicago

Arizona

  • Banner University of Arizona Medical Center — Tucson

Arkansas

  • Arkansas Children's Hospital — Little Rock

District of Columbia

  • Children's National Medical Center — Washington D.C.

Georgia

  • Atlanta Allergy & Asthma Clinic, PA — Marietta

Trial Details

FieldValue
Enrollment Target 555 participants
Start Date 2015-12-22
Est. Completion 2018-07-02
Phase Phase 3

Sponsor

Aimmune Therapeutics

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02635776

The ClinicalTrials.gov registry entry for NCT02635776 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 555 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 AR101 powder provided in capsules & sachets 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: NCT02635776 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Colorado, Florida. 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 NCT02635776 about?

NCT02635776 is a clinical study titled "Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)". The purpose of this study is to demonstrate the efficacy and safety of AR101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

What is the current status of trial NCT02635776?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2015-12-22. Estimated completion is 2018-07-02.

What conditions does trial NCT02635776 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 NCT02635776?

The interventions under investigation include: AR101 powder provided in capsules & sachets (BIOLOGICAL), Placebo powder provided in capsules & sachets (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02635776?

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 NCT02635776 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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