Last updated on May 2019

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


Brief description of study

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 double-blind placebo-controlled food challenge (DBPCFC) at week 28.

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 DBPCFC at week 28
  • 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 DBPCFC at week 52
  • 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 DBPCFC at week 52
  • 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 G4 (IgG4), and peanut-specific IgG4/IgE ratio
  • To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (e-diary) during the up-dosing phase

Clinical Study Identifier: NCT03682770

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Regeneron Investigational Site

Birmingham, AL United States
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Regeneron Investigational Site

Little Rock, AR United States
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Regeneron Investigational Site

Mission Viejo, CA United States
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Regeneron Investigational Site

Mountain View, CA United States
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Regeneron Investigational Site

Rolling Hills Estates, CA United States
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Regeneron Investigational Site

Washington, WA United States
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Regeneron Investigational Site

Ypsilanti, MI United States
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Regeneron Investigational Site

Minneapolis, MN United States
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Regeneron Investigational Site

Ocean Township, NJ United States
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Regeneron Investigational Site

Philadelphia, PA United States
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Recruitment Status: Open


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