Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682770
Recruitment Status : Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
Sanofi
Aimmune Therapeutics, Inc.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Dupilumab Drug: Placebo matching dupilumab Drug: AR101 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : December 24, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: dupilumab + AR101
Participant randomization of a ratio of 2 active dupilumab arms
Drug: Dupilumab
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)

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

Experimental: placebo matching dupilumab + AR101
Participant randomization of a ratio of 1 placebo arm
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




Primary Outcome Measures :
  1. Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who "pass" a post up-dosing double-blind, placebo-controlled food challenge (DBPCFC) with 2044 mg (cumulative) peanut protein [ Time Frame: Up to 40 weeks ]

Secondary Outcome Measures :
  1. Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants treated with dupilumab plus AR101 vs placebo plus AR101 [ Time Frame: Up to 40 weeks ]
  2. Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reach the dose of AR101 [ Time Frame: Up to 40 weeks ]
  3. Time from randomization to the first time when participants reach the dose of AR101 [ Time Frame: Up to 40 weeks ]
  4. Proportion of participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 who "pass" a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein [ Time Frame: Up to 64 weeks ]
  5. Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 [ Time Frame: Up to 64 weeks ]
  6. Proportion of participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 who "pass" a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein [ Time Frame: Up to 64 weeks ]
  7. Change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC in participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 [ Time Frame: Up to 64 weeks ]
  8. Percent change in peanut-specific Immunoglobulin E (IgE) in participants treated with dupilumab plus AR101 vs participants treated placebo plus AR101 [ Time Frame: Up to 40 weeks ]
  9. Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated placebo plus AR101 [ Time Frame: Up to 64 weeks ]
  10. Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated placebo plus AR101 [ Time Frame: Up to 76 weeks ]
  11. Proportion of participants experiencing symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline up to 40 weeks ]
  12. Proportion of participants experiencing mild, moderate, or severe symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline up to 40 weeks ]
  13. Difference in mean/median duration of symptoms by treatment group measured by the daily symptom e-diary [ Time Frame: Baseline up to 40 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682770


Locations
Layout table for location information
United States, Alabama
Regeneron Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Regeneron Investigational Site
Tucson, Arizona, United States, 85724
United States, Arkansas
Regeneron Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
Regeneron Investigational Site
Los Angeles, California, United States, 90027
Regeneron Investigational Site
Los Angeles, California, United States, 90095
Regeneron Investigational Site
Mission Viejo, California, United States, 92691
Regeneron Investigational Site
Mountain View, California, United States, 94040
Regeneron Investigational Site
Rolling Hills Estates, California, United States, 90274
United States, Colorado
Regeneron Investigational Site
Denver, Colorado, United States, 80206
United States, District of Columbia
Regeneron Investigational Site
Washington, District of Columbia, United States, 20010
United States, Florida
Regeneron Investigational Site
Tampa, Florida, United States, 33612
United States, Georgia
Regeneron Investigational Site
Atlanta, Georgia, United States, 30329
Regeneron Investigational Site
Marietta, Georgia, United States, 30144
United States, Illinois
Regeneron Investigational Site
Chicago, Illinois, United States, 60611
United States, Maryland
Regeneron Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Regeneron Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
Regeneron Investigational Site
Ann Arbor, Michigan, United States, 48106
Regeneron Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Regeneron Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, New Jersey
Regeneron Investigational Site
Ocean Township, New Jersey, United States, 07712
United States, New York
Regeneron Investigational Site
Great Neck, New York, United States, 11021
Regeneron Investigational Site
New York, New York, United States, 10029
United States, North Carolina
Regeneron Investigational Site
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Regeneron Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Regeneron Investigational Site
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Aimmune Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03682770    
Other Study ID Numbers: R668-ALG-16114
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs