Clinical Trials Logo
  1. Home
  2. Peanut Allergy
  3. NCT05424731

Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children

Peanut Allergy Clinical Trial

Official title:
Viaskin® Peanut (DBV712) Compassionate Use in Peanut-allergic Children Previously Enrolled in a DBV712 Clinical Study

Clinical Trial Summary

This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.

Clinical Trial Description

This study is an open-label Expanded Access Protocol to provide continued treatment with DBV712 for individuals completing a DBV clinical study. Participation is by invitation according to the inclusion criteria. For individuals who have received DBV712 for longer than one year prior to entry into this protocol, where treatment allocation is unblinded, safety assessment and resupply of DBV712 will occur at 6-month intervals. There will be no other scheduled study visits. For individuals who have been on blinded treatment, a safety assessment will be conducted at Months 1 and 3. Visits for safety assessment and resupply of DBV712 will occur at 3-month intervals during the first 12 months. After a year, visits will occur at 6-month intervals. DBV712 will be supplied to participants at study visits to suffice until the next visit. For individuals who have been on blinded treatment, or off DBV712 treatment for more than 14 days prior to entry into this protocol, dosing consists of approximately 6 hours for the first week, 12 hours for the second week, then once daily, at approximately the same time of day. Treatment with DBV712 will continue until, in the clinical judgement of the treating physician, the participant is no longer benefiting from continuation of the treatment, DBV712 is approved and available by prescription, or the study is terminated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05424731
Study type Expanded Access
Source DBV Technologies
Contact Anne B Cropp, Pharm. D.
Phone 1-888-441-793
Email DBV712.eap@earlyaccesscare.com
Status Available
Phase
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 NCT01955109 - Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children Phase 2
Completed NCT01950533 - The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
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 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
Completed NCT03352726 - A Study to Assess the Biological Potency of Peanut Allergen Extract in Adolescent and Adult Peanut Allergic Subjects Phase 1