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NCT05741476 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
A Phase 3 study of Allergy, Peanut, sponsored by DBV Technologies.
- Active
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT05741476: Active Phase 3 study of Allergy, Peanut, sponsored by DBV Technologies.
NCT05741476 is a Phase 3 study of Allergy, Peanut that is active but no longer recruiting, run by DBV Technologies. The registered enrollment target is 600 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05741476, a Phase 3 study of Allergy, Peanut, is active but no longer recruiting, sponsored by DBV Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG DBV712
Study Locations (20)
California
- DBV Investigative Site - Los Angeles
- DBV Investigative Site - Los Angeles
- DBV Investigative site - Mission Viejo
- DBV Investigative Site - San Diego
- DBV Investigative Site - San Francisco
- DBV Investigative Site - San Jose
Florida
- DBV Investigative Site - Hollywood
- DBV Investigative Site - Miami
- DBV Investigative Site - St. Petersburg
- DBV Investigative Site - Tampa
Colorado
- DBV Investigative Site - Aurora
- DBV Investigative Site - Colorado Springs
Georgia
- DBV Investigative site - Atlanta
- DBV Investigative Site - Marietta
Illinois
- DBV Investigative Site - Chicago
- DBV Investigative Site - Normal
Alabama
- DBV Investigative Site - Birmingham
Arizona
- DBV Investigative Site - Tucson
Arkansas
- DBV Investigative Site - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2023-02-21 |
| Est. Completion | 2029-10 |
| Phase | Phase 3 |
What the registry record for NCT05741476 still lists
NCT05741476 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Allergy, Peanut appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05741476 names 20 study sites across 9 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT05741476 about?
NCT05741476 is a clinical study titled "Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age". 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.
What is the current status of trial NCT05741476?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2023-02-21. Estimated completion is 2029-10.
What conditions does trial NCT05741476 study?
This clinical trial studies the following conditions: Allergy, Peanut.
What interventions are being tested in trial NCT05741476?
The interventions under investigation include: Placebo (OTHER), DBV712 (DRUG).
Who is sponsoring clinical trial NCT05741476?
This trial is sponsored by DBV Technologies, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05741476 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05741476's enrollment target sits among peer trials
600 608th of 2000 higher than 1,363 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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