Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
Condition(s) studied
Investigational drug(s) / intervention(s)
DBV712: DBV712 250 mcg epicutaneous system.
Placebo: DBV712 matching placebo epicutaneous system.
DBV712: DBV712 250 mcg epicutaneous system.
Study summary
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.
Eligibility
Primary outcome measure(s)
- DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group — At Month 12
A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was \> 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 250 mcg group compared to the placebo group after 12 months of treatment in the target population will be reported.
Trial sites (87)
| Facility | City | Region | Status |
|---|---|---|---|
| DBV Investigative Site | Birmingham | Alabama | |
| DBV Investigative Site | Tucson | Arizona | |
| DBV Investigative Site | Little Rock | Arkansas | |
| DBV Investigative Site | Los Angeles | California | |
| DBV Investigative Site | Los Angeles | California | |
| DBV Investigative site | Mission Viejo | California | |
| DBV Investigative Site | San Diego | California | |
| DBV Investigative Site | San Francisco | California | |
| DBV Investigative Site | San Jose | California | |
| DBV Investigative Site | Aurora | Colorado | |
| DBV Investigative Site | Colorado Springs | Colorado | |
| DBV Investigative Site | Washington D.C. | District of Columbia | |
| DBV Investigative Site | Hollywood | Florida | |
| DBV Investigative Site | Miami | Florida | |
| DBV Investigative Site | St. Petersburg | Florida | |
| DBV Investigative Site | Tampa | Florida | |
| DBV Investigative site | Atlanta | Georgia | |
| DBV Investigative Site | Marietta | Georgia | |
| DBV Investigative Site | Chicago | Illinois | |
| DBV Investigative Site | Normal | Illinois | |
| DBV Investigative Site | Indianapolis | Indiana | |
| DBV Investigative Site | Louisville | Kentucky | |
| DBV Investigative Site | Baltimore | Maryland | |
| DBV Investigative Site | Chevy Chase | Maryland | |
| DBV Investigative Site | Boston | Massachusetts | |
| DBV Investigative Site | Boston | Massachusetts | |
| DBV Investigative Site | Taunton | Massachusetts | |
| DBV Investigative Site | Ann Arbor | Michigan | |
| DBV Investigative Site | Ypsilanti | Michigan | |
| DBV Investigative Site | Maplewood | Minnesota | |
| DBV Investigative Site | Kansas City | Missouri | |
| DBV Investigative Site | Great Neck | New York | |
| DBV Investigative Site | New York | New York | |
| DBV Investigative Site | New York | New York | |
| DBV Investigative Site | Rochester | New York | |
| DBV Investigative Site | Chapel Hill | North Carolina | |
| DBV Investigative Site | Cincinnati | Ohio | |
| DBV Investigative Site | Cleveland | Ohio | |
| DBV Investigative Site | Cleveland | Ohio | |
| DBV Investigative Site | Columbus | Ohio |
+ 47 more sites — see the full list on the official registry below.
More DBV Technologies trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05741476 on ClinicalTrials.gov ↗ ← All trials in Spain