Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Public ClinicalTrials.gov record NCT03682770. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03682770
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 148 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 3, 2018 (Actual)
- Primary completion
- Oct 16, 2020 (Actual)
- Completion
- Jul 23, 2021 (Actual)
- Last update posted
- Feb 7, 2024
2018 – 2021
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Investigational Site | Birmingham | Alabama | 35209 | — |
| Regeneron Investigational Site | Tucson | Arizona | 85724 | — |
| Regeneron Investigational Site | Little Rock | Arkansas | 72202 | — |
| Regeneron Investigational Site | Los Angeles | California | 90027 | — |
| Regeneron Investigational Site | Los Angeles | California | 90095 | — |
| Regeneron Investigational Site | Mission Viejo | California | 92691 | — |
| Regeneron Investigational Site | Mountain View | California | 94040 | — |
| Regeneron Investigational Site | Rolling Hills Estates | California | 90274 | — |
| Regeneron Investigational Site | Denver | Colorado | 80206 | — |
| Regeneron Investigational Site | Washington D.C. | District of Columbia | 20010 | — |
| Regeneron Investigational Site | Tampa | Florida | 33612 | — |
| Regeneron Investigational Site | Atlanta | Georgia | 30329 | — |
| Regeneron Investigational Site | Marietta | Georgia | 30144 | — |
| Regeneron Investigational Site | Chicago | Illinois | 60611 | — |
| Regeneron Investigational Site | Baltimore | Maryland | 21287 | — |
| Regeneron Investigational Site | Boston | Massachusetts | 02114 | — |
| Regeneron Investigational Site | Ann Arbor | Michigan | 48106 | — |
| Regeneron Investigational Site | Ypsilanti | Michigan | 48197 | — |
| Regeneron Investigational Site | Minneapolis | Minnesota | 55402 | — |
| Regeneron Investigational Site | Ocean Township | New Jersey | 07712 | — |
| Regeneron Investigational Site | Great Neck | New York | 11021 | — |
| Regeneron Investigational Site | New York | New York | 10029 | — |
| Regeneron Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| Regeneron Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| Regeneron Investigational Site | Seattle | Washington | 98115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03682770, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 7, 2024 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03682770 live on ClinicalTrials.gov.