FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

AR101 Real-World Open-Label Extension Study

Study Purpose

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 4 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - Received AR101 in study ARC007 - Completed the ARC007 study - Use of effective birth control by sexually active female subjects of childbearing potential Key

    Exclusion Criteria:

    - Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
  • - Receiving a prohibited medication or anticipated use of a prohibited medication [e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
  • - Currently in the build-up phase of immunotherapy for any nonfood allergen.
  • - Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03337542

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Aimmune Therapeutics, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Freddy Byrth
Principal Investigator Affiliation Director, Clinical Operations

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Active, not recruiting
Countries Canada, United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Peanut Allergy
Study Website: View Trial Website
Additional Details

This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial and completed the study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

ASTHMA Inc. Clinical Research Center, Seattle, Washington

Status

Address

ASTHMA Inc. Clinical Research Center

Seattle, Washington, 98115-2024

Virginia Mason Medical Center, Seattle, Washington

Status

Address

Virginia Mason Medical Center

Seattle, Washington, 98101

Central Texas Health Research, New Braunfels, Texas

Status

Address

Central Texas Health Research

New Braunfels, Texas, 78130

Houston, Texas

Status

Address

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030

Western Sky Medical Research, El Paso, Texas

Status

Address

Western Sky Medical Research

El Paso, Texas, 79903

Children's Health, Dallas, Texas

Status

Address

Children's Health

Dallas, Texas, 75235

Austin, Texas

Status

Address

Specially for Children Allergy, Asthma and Immunology Clinic

Austin, Texas, 78723

North Charleston, South Carolina

Status

Address

National Allergy and Asthma Research, LLC

North Charleston, South Carolina, 29420

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Baker Allergy, Asthma and Dermatology, Portland, Oregon

Status

Address

Baker Allergy, Asthma and Dermatology

Portland, Oregon, 97223

Columbia Asthma & Allergy Clinic, Clackamas, Oregon

Status

Address

Columbia Asthma & Allergy Clinic

Clackamas, Oregon, 97015

Oklahoma City, Oklahoma

Status

Address

Oklahoma Institute of Allergy and Asthma Clinical Research, LLC

Oklahoma City, Oklahoma, 73131

Bernstein Clinical Research Center, Cincinnati, Ohio

Status

Address

Bernstein Clinical Research Center

Cincinnati, Ohio, 45231

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Clinical Research of Charlotte, Charlotte, North Carolina

Status

Address

Clinical Research of Charlotte

Charlotte, North Carolina, 28277

Chapel Hill, North Carolina

Status

Address

University of North Carolina at Chapel Hill, Clinical & Translational Research Center

Chapel Hill, North Carolina, 27599

Rochester, New York

Status

Address

Univ. of Rochester Medical Center, Golisano Children's Hosp.

Rochester, New York, 14642

Northwell Health System, Great Neck, New York

Status

Address

Northwell Health System

Great Neck, New York, 11021

Princeton Center for Clinical Research, Skillman, New Jersey

Status

Address

Princeton Center for Clinical Research

Skillman, New Jersey, 08558

Atlantic Research Center, Ocean City, New Jersey

Status

Address

Atlantic Research Center

Ocean City, New Jersey, 07712

Children's Mercy on Broadway, Kansas City, Missouri

Status

Address

Children's Mercy on Broadway

Kansas City, Missouri, 64111

Clinical Research Institute, Inc., Plymouth, Minnesota

Status

Address

Clinical Research Institute, Inc.

Plymouth, Minnesota, 55441

Ann Arbor, Michigan

Status

Address

University of Michigan Division of Allergy and Clinical Immunology

Ann Arbor, Michigan, 48106

Boston Children's Hospital, Boston, Massachusetts

Status

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Baltimore, Maryland

Status

Address

Johns Hopkins Hospital, Pediatric Clinical Research Unit

Baltimore, Maryland, 21287

Chesapeake Clinical Research, Inc., Baltimore, Maryland

Status

Address

Chesapeake Clinical Research, Inc.

Baltimore, Maryland, 21236

Louisville, Kentucky

Status

Address

Family Allergy & Asthma Research Institute

Louisville, Kentucky, 40215

Deaconess Clinic Downtown, Evansville, Indiana

Status

Address

Deaconess Clinic Downtown

Evansville, Indiana, 47713

Sneeze, Wheeze, & Itch Associates, LLC, Normal, Illinois

Status

Address

Sneeze, Wheeze, & Itch Associates, LLC

Normal, Illinois, 61761

Chicago, Illinois

Status

Address

The University of Chicago Medicine, Comer Children's Hospital

Chicago, Illinois, 60637

Chicago, Illinois

Status

Address

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

Chicago, Illinois, 60611-2605

Idaho Allergy and Research, Eagle, Idaho

Status

Address

Idaho Allergy and Research

Eagle, Idaho, 83616

Atlanta Allergy & Asthma Clinic, Marietta, Georgia

Status

Address

Atlanta Allergy & Asthma Clinic

Marietta, Georgia, 30060

Tampa, Florida

Status

Address

University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit

Tampa, Florida, 33613

Sarasota, Florida

Status

Address

Sarasota Clinical Research Windom Allergy, Asthma and Sinus

Sarasota, Florida, 34239

Allergy Associates of the Palm Beaches, North Palm Beach, Florida

Status

Address

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408

Largo, Florida

Status

Address

Sher Allergy Specialists - Center for Cough

Largo, Florida, 33778

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Colorado Allergy & Asthma Centers, P.C., Denver, Colorado

Status

Address

Colorado Allergy & Asthma Centers, P.C.

Denver, Colorado, 80230

National Jewish Health, Denver, Colorado

Status

Address

National Jewish Health

Denver, Colorado, 80206

Asthma & Allergy Associates, Colorado Springs, Colorado

Status

Address

Asthma & Allergy Associates

Colorado Springs, Colorado, 80907

Children's Hospital Colorado, Aurora, Colorado

Status

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Bay Area Allergy, Walnut Creek, California

Status

Address

Bay Area Allergy

Walnut Creek, California, 94598

UCLA Medical Center, Santa Monica, Santa Monica, California

Status

Address

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404

San Jose, California

Status

Address

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117

San Francisco, California

Status

Address

UCSF, Benioff Children's Hospital - Allergy and Immunology

San Francisco, California, 95148

San Diego, California

Status

Address

Rady Children's Hospital, Div. Allergy & Immunology, UC San Diego

San Diego, California, 92123

San Diego, California

Status

Address

Allergy & Asthma Medical Group and Research Center

San Diego, California, 92123

Peninsula Research Associates, Rolling Hills Estates, California

Status

Address

Peninsula Research Associates

Rolling Hills Estates, California, 90274

Mountain View, California

Status

Address

Sean N. Parker Center for Allergy Research at Stanford University - Packard-El Camino Hospital

Mountain View, California, 94040

Mission Viejo, California

Status

Address

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 92691

Los Angeles, California

Status

Address

Children's Hospital Los Angeles, Division of Clinical Immunology and Allergy

Los Angeles, California, 90027

Jonathan Corren, M.D., Inc., Los Angeles, California

Status

Address

Jonathan Corren, M.D., Inc.

Los Angeles, California, 90025

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

Tucson, Arizona

Status

Address

Banner University of Arizona Medical Center

Tucson, Arizona, 85724

Medical Research of Arizona, Scottsdale, Arizona

Status

Address

Medical Research of Arizona

Scottsdale, Arizona, 85251

Clinical Research Center of Alabama, Birmingham, Alabama

Status

Address

Clinical Research Center of Alabama

Birmingham, Alabama, 35209

International Sites

Gordon Sussman Clinical Research, Toronto, Ontario, Canada

Status

Address

Gordon Sussman Clinical Research

Toronto, Ontario, M4V 1R2

Ottawa Allergy Research Corp, Ottawa, Ontario, Canada

Status

Address

Ottawa Allergy Research Corp

Ottawa, Ontario, K1G 6C6

Cheema Research Inc. (CRI), Mississauga, Ontario, Canada

Status

Address

Cheema Research Inc. (CRI)

Mississauga, Ontario, L5A 3V4

Triple A Lab / Hamilton Allergy, Hamilton, Ontario, Canada

Status

Address

Triple A Lab / Hamilton Allergy

Hamilton, Ontario, L8S 1G5

McMaster University Medical Center, Hamilton, Ontario, Canada

Status

Address

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.