Clinical Trials Logo
  1. Home
  2. Peanut Allergy
  3. NCT03793608

Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Peanut Allergy Clinical Trial

Official title:
A Study to Evaluate the Efficacy and Safety of Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03793608
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date March 12, 2019
Completion date May 12, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05667610 - Immune-supportive Diet and Gut Permeability in Allergic Children N/A
Recruiting NCT05440643 - Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy Phase 1
Terminated NCT03849079 - Validation of the HYPONUT Product N/A
Completed NCT02979600 - Clinical and Biological Efficacy of Peanut Oral Immunotherapy N/A
Completed NCT01950533 - The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
Completed NCT01955109 - Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children Phase 2
Recruiting NCT04415593 - High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety N/A
Active, not recruiting NCT04511494 - Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT N/A
Active, not recruiting NCT04887441 - Allergology: Information, Data and Knowledge Organization
Active, not recruiting NCT04881773 - Oral Low Doses Tolerance INduction Study for Peanuts
Completed NCT03682770 - Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy) Phase 2
Terminated NCT03703791 - Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents Phase 3
Completed NCT02916446 - Safety Study of Viaskin Peanut to Treat Peanut Allergy Phase 3
Active, not recruiting NCT02402231 - Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy Phase 2
Completed NCT03337542 - AR101 Real-World Open-Label Extension Study Phase 3
Recruiting NCT05476497 - Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects Phase 1
Completed NCT03648320 - The Grown Up Peanut Immunotherapy Study N/A
Completed NCT03292484 - Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008) Phase 3
Completed NCT03852342 - Reactive Doses and Times During Oral Food Challenge to Peanut
Recruiting NCT05138757 - Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy Phase 1/Phase 2