Back to resultsStudy in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary Purpose
Peanut Allergy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dupilumab
Placebo matching dupilumab
AR101
Sponsored by
About this trial
This is an interventional treatment trial for Peanut Allergy
Eligibility 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
Sites / Locations
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
dupilumab + AR101
placebo matching dupilumab + AR101
Arm Description
Participant randomization of a ratio of 2 active dupilumab arms
Participant randomization of a ratio of 1 placebo arm
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reach the protocol defined dose of AR101
Time from randomization to the first time when participants reach the protocol defined dose of AR101
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
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
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
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
Percent change in peanut-specific Immunoglobulin E (IgE) in participants treated with dupilumab plus AR101 vs participants treated placebo plus AR101
Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated placebo plus AR101
Percent change in peanut-specific IgE in participants (continuously) treated with dupilumab plus AR101 vs participants treated placebo plus AR101
Proportion of participants experiencing allergic symptoms by treatment group measured by the daily symptom e-diary
Allergic severity of each symptom will be rated on a scale of 1-10. (1 = Not Bad, 10 = Terribly Bad)
Mean severity score for each symptom by treatment group measured by the daily symptom e-diary
Maximum severity score for each symptom by treatment group measured by the daily symptom e-diary
Difference in mean/median duration of symptoms by treatment group measured by the daily symptom e-diary
Full Information
NCT ID
NCT03682770
First Posted
September 21, 2018
Last Updated
October 12, 2022
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi, Aimmune Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03682770
Brief Title
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
October 16, 2020 (Actual)
Study Completion Date
July 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi, Aimmune Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dupilumab + AR101
Arm Type
Experimental
Arm Description
Participant randomization of a ratio of 2 active dupilumab arms
Arm Title
placebo matching dupilumab + AR101
Arm Type
Experimental
Arm Description
Participant randomization of a ratio of 1 placebo arm
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Intervention Description
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)
Intervention Type
Drug
Intervention Name(s)
Placebo matching dupilumab
Intervention Description
Placebo matching dupilumab is prepared in the same formulation without the addition of protein
Intervention Type
Drug
Intervention Name(s)
AR101
Intervention Description
AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Proportion of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reach the protocol defined dose of AR101
Time Frame
Up to 40 weeks
Title
Time from randomization to the first time when participants reach the protocol defined dose of AR101
Time Frame
Up to 40 weeks
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Proportion of participants experiencing allergic symptoms by treatment group measured by the daily symptom e-diary
Description
Allergic severity of each symptom will be rated on a scale of 1-10. (1 = Not Bad, 10 = Terribly Bad)
Time Frame
Baseline up to 40 weeks
Title
Mean severity score for each symptom by treatment group measured by the daily symptom e-diary
Time Frame
Baseline up to 40 weeks
Title
Maximum severity score for each symptom by treatment group measured by the daily symptom e-diary
Time Frame
Baseline up to 40 weeks
Title
Difference in mean/median duration of symptoms by treatment group measured by the daily symptom e-diary
Time Frame
Baseline up to 40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Regeneron Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Regeneron Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Regeneron Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Regeneron Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Regeneron Investigational Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Regeneron Investigational Site
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Regeneron Investigational Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Regeneron Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Regeneron Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Regeneron Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Regeneron Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Regeneron Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30144
Country
United States
Facility Name
Regeneron Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Regeneron Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Regeneron Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Regeneron Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Regeneron Investigational Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Regeneron Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Regeneron Investigational Site
City
Ocean Township
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Regeneron Investigational Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Regeneron Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Regeneron Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Regeneron Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Regeneron Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
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