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Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)

Study Purpose

Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing double-blind placebo-controlled food challenge (DBPCFC) at visit 16. Secondary objectives are:

  • - To assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a post up-dosing DBPCFC at visit 16.
  • - To assess whether dupilumab as (indefinite [continuously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22.
  • - To assess whether dupilumab as (limited [previously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22.
  • - To evaluate the safety and tolerability of dupilumab as adjunct to AR101 compared to placebo.
  • - To assess the effect of dupilumab (compared to placebo) as adjunct to AR101 on the change in peanut-specific Immunoglobulin E (sIgE), Immunoglobulin G (IgG), Immunoglobulin G4 (IgG4), and peanut-specific IgG4/IgE ratio.
- To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (electronic diary [e-diary]) during the up-dosing phase

Recruitment Criteria

Accepts Healthy Volunteers

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

No
Study Type

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.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

  • - Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening and not experiencing dose-limiting symptoms to placebo as defined in the protocol.
  • - Serum Immunoglobulin E (IgE) to peanut of ≥10 kUA/L and/or a skin prick test (SPT) to peanut ≥8 mm compared to a negative control.
  • - Participants/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study.
  • - Participants with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study.
Key

Exclusion Criteria:

  • - History of other chronic disease (other than asthma, Atopic Dermatitis (AD), or allergic rhinitis) requiring therapy (eg, heart disease, diabetes, hypertension) that would represent a risk to participant's health or safety in this study or ability to comply with study protocol.
  • - History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock.
  • - History of eosinophilic Gastrointestinal (GI) disease.
  • - Asthma at time of enrollment with any of the following: - Forced Expiratory Volume 1 Second (FEV1) <80% of predicted or ratio of FEV1 to forced vital capacity (FEV1/FVC) <75% of predicted with or without controller medications.
  • - Inhaled corticosteroids (ICS) dosing of daily fluticasone (or equivalent ICS based on NHLBI dosing chart) - One hospitalization in the past year for asthma.
  • - Emergency room visit for asthma within 6 months prior to screening.
  • - Use of systemic corticosteroids within 2 months prior to screening.
  • - Use of other forms of allergen immunotherapy or immunomodulatory therapy within 3 months prior to screening.
  • - Use of any agents known or likely to interact with epinephrine (eg, beta-blockers, angiotensin converting enzyme-inhibitors, tri-cyclic antidepressants, or other drugs), within 3 weeks prior to screening.
- Allergy to oat (placebo in DBPCFC) Note: Other protocol Inclusion/Exclusion Criteria apply

Trial Details

Trial ID:

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.

NCT03682770
Phase

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 2
Lead Sponsor

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

Regeneron Pharmaceuticals
Principal Investigator

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

Clinical Trial Management
Principal Investigator Affiliation Regeneron Pharmaceuticals
Agency Class

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

Industry
Overall Status Active, not recruiting
Countries United States
Conditions

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

Peanut Allergy
Arms & Interventions

Arms

Experimental: dupilumab + AR101

Participant randomization of a ratio of 2 active dupilumab arms

Experimental: placebo matching dupilumab + AR101

Participant randomization of a ratio of 1 placebo arm

Interventions

Drug: - Dupilumab

Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)

Drug: - Placebo matching dupilumab

Placebo matching dupilumab is prepared in the same formulation without the addition of protein

Drug: - AR101

AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase

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.

Regeneron Investigational Site, Birmingham, Alabama

Status

Address

Regeneron Investigational Site

Birmingham, Alabama, 35209

Regeneron Investigational Site, Tucson, Arizona

Status

Address

Regeneron Investigational Site

Tucson, Arizona, 85724

Regeneron Investigational Site, Little Rock, Arkansas

Status

Address

Regeneron Investigational Site

Little Rock, Arkansas, 72202

Regeneron Investigational Site, Los Angeles, California

Status

Address

Regeneron Investigational Site

Los Angeles, California, 90027

Regeneron Investigational Site, Los Angeles, California

Status

Address

Regeneron Investigational Site

Los Angeles, California, 90095

Regeneron Investigational Site, Mission Viejo, California

Status

Address

Regeneron Investigational Site

Mission Viejo, California, 92691

Regeneron Investigational Site, Mountain View, California

Status

Address

Regeneron Investigational Site

Mountain View, California, 94040

Regeneron Investigational Site, Rolling Hills Estates, California

Status

Address

Regeneron Investigational Site

Rolling Hills Estates, California, 90274

Regeneron Investigational Site, Denver, Colorado

Status

Address

Regeneron Investigational Site

Denver, Colorado, 80206

Regeneron Investigational Site, Washington, District of Columbia

Status

Address

Regeneron Investigational Site

Washington, District of Columbia, 20010

Regeneron Investigational Site, Tampa, Florida

Status

Address

Regeneron Investigational Site

Tampa, Florida, 33612

Regeneron Investigational Site, Atlanta, Georgia

Status

Address

Regeneron Investigational Site

Atlanta, Georgia, 30329

Regeneron Investigational Site, Marietta, Georgia

Status

Address

Regeneron Investigational Site

Marietta, Georgia, 30144

Regeneron Investigational Site, Chicago, Illinois

Status

Address

Regeneron Investigational Site

Chicago, Illinois, 60611

Regeneron Investigational Site, Baltimore, Maryland

Status

Address

Regeneron Investigational Site

Baltimore, Maryland, 21287

Regeneron Investigational Site, Boston, Massachusetts

Status

Address

Regeneron Investigational Site

Boston, Massachusetts, 02114

Regeneron Investigational Site, Ann Arbor, Michigan

Status

Address

Regeneron Investigational Site

Ann Arbor, Michigan, 48106

Regeneron Investigational Site, Ypsilanti, Michigan

Status

Address

Regeneron Investigational Site

Ypsilanti, Michigan, 48197

Regeneron Investigational Site, Minneapolis, Minnesota

Status

Address

Regeneron Investigational Site

Minneapolis, Minnesota, 55402

Regeneron Investigational Site, Ocean Township, New Jersey

Status

Address

Regeneron Investigational Site

Ocean Township, New Jersey, 07712

Regeneron Investigational Site, Great Neck, New York

Status

Address

Regeneron Investigational Site

Great Neck, New York, 11021

Regeneron Investigational Site, New York, New York

Status

Address

Regeneron Investigational Site

New York, New York, 10029

Regeneron Investigational Site, Chapel Hill, North Carolina

Status

Address

Regeneron Investigational Site

Chapel Hill, North Carolina, 27599

Regeneron Investigational Site, Philadelphia, Pennsylvania

Status

Address

Regeneron Investigational Site

Philadelphia, Pennsylvania, 19104

Regeneron Investigational Site, Seattle, Washington

Status

Address

Regeneron Investigational Site

Seattle, Washington, 98115

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