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NCT03793608 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03793608 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 25 participants.
The verdict
NCT03793608, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Dupilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2021-05-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03793608
The ClinicalTrials.gov registry entry for NCT03793608 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dupilumab is the first listed.
NCT03793608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03793608 about?
NCT03793608 is a clinical study titled "Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy". 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 we...
What is the current status of trial NCT03793608?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2019-03-12. Estimated completion is 2021-05-12.
What interventions are being tested in trial NCT03793608?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT03793608?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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