Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
NCT ID: NCT03682770
Last Updated: 2024-02-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2018-10-03
2021-07-23
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dupilumab + AR101
Participant randomization of a ratio of 2 active dupilumab arms
Dupilumab
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)
AR101
AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
placebo matching dupilumab + AR101
Participant randomization of a ratio of 1 placebo arm
Placebo matching dupilumab
Placebo matching dupilumab is prepared in the same formulation without the addition of protein
AR101
AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
Interventions
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Dupilumab
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)
Placebo matching dupilumab
Placebo matching dupilumab is prepared in the same formulation without the addition of protein
AR101
AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
6 Years
17 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Aimmune Therapeutics, Inc.
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Tucson, Arizona, United States
Regeneron Investigational Site
Little Rock, Arkansas, United States
Regeneron Investigational Site
Los Angeles, California, United States
Regeneron Investigational Site
Los Angeles, California, United States
Regeneron Investigational Site
Mission Viejo, California, United States
Regeneron Investigational Site
Mountain View, California, United States
Regeneron Investigational Site
Rolling Hills Estates, California, United States
Regeneron Investigational Site
Denver, Colorado, United States
Regeneron Investigational Site
Washington D.C., District of Columbia, United States
Regeneron Investigational Site
Tampa, Florida, United States
Regeneron Investigational Site
Atlanta, Georgia, United States
Regeneron Investigational Site
Marietta, Georgia, United States
Regeneron Investigational Site
Chicago, Illinois, United States
Regeneron Investigational Site
Baltimore, Maryland, United States
Regeneron Investigational Site
Boston, Massachusetts, United States
Regeneron Investigational Site
Ann Arbor, Michigan, United States
Regeneron Investigational Site
Ypsilanti, Michigan, United States
Regeneron Investigational Site
Minneapolis, Minnesota, United States
Regeneron Investigational Site
Ocean Township, New Jersey, United States
Regeneron Investigational Site
Great Neck, New York, United States
Regeneron Investigational Site
New York, New York, United States
Regeneron Investigational Site
Chapel Hill, North Carolina, United States
Regeneron Investigational Site
Philadelphia, Pennsylvania, United States
Regeneron Investigational Site
Seattle, Washington, United States
Countries
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References
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Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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R668-ALG-16114
Identifier Type: -
Identifier Source: org_study_id
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