Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03793608
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2019-01-02
Brief Title:
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003133-15 | EUDRACT_NUMBER | None | None |