Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Public ClinicalTrials.gov record NCT03793608. 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.
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Official title
A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who safely pass a double-blind placebo-controlled food challenge (DBPCFC) at week 24. The secondary objectives are: * To determine whether dupilumab treatment improves peanut tolerability, defined as a change in the cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC * To evaluate the safety and tolerability of dupilumab treatment in peanut allergic patients * To evaluate the effects of dupilumab treatment on the levels of peanut-specific Immunoglobulin E (IgE) * To evaluate the treatment effect of dupilumab on the average wheal size after a titrated skin prick test (SPT), as measured by area under curve (AUC) of the average wheal size induced by peanut extract at different concentrations * To assess the incidence of treatment-emergent anti-drug antibodies (ADA) to dupilumab in patients over time
Study identification
- NCT ID
- NCT03793608
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 25 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
- Mar 12, 2019 (Actual)
- Primary completion
- Feb 19, 2021 (Actual)
- Completion
- May 12, 2021 (Actual)
- Last update posted
- May 19, 2022
2019 – 2021
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Investigational Site | Mountain View | California | 94305 | — |
| Regeneron Investigational Site | Tampa | Florida | 33612 | — |
| Regeneron Investigational Site | Indianapolis | Indiana | 46202 | — |
| Regeneron Investigational Site | Ypsilanti | Michigan | 48197 | — |
| Regeneron Investigational Site | Great Neck | New York | 11021 | — |
| Regeneron Investigational Site | The Bronx | New York | 10461 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03793608, 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 May 19, 2022 · Synced Nov 9, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03793608 live on ClinicalTrials.gov.