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NCT03211247 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
A Phase 3 study, sponsored by DBV Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 414
- Enrollment target
NCT03211247: Completed Phase 3 study, sponsored by DBV Technologies.
NCT03211247 is a Phase 3 study that has completed, run by DBV Technologies. The registered enrollment target is 414 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03211247, a Phase 3 study, has completed, sponsored by DBV Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 414 participants
- Enrollment target
Study Summary
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
Primary Outcome
A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
Interventions
- BIOLOGICAL Part B Placebo
- BIOLOGICAL Part A Viaskin Peanut 250 mcg
- BIOLOGICAL Part A Viaskin Peanut 100 mcg
- BIOLOGICAL Part A Placebo
- BIOLOGICAL Part B Viaskin Peanut 250 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 3 |
What the finished NCT03211247 record still lists
NCT03211247 is an interventional study that assigns participants to a tested intervention. The registered 414 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 (46% lower).
The record links to 0 conditions, and to 5 interventions - of which Part B Placebo is the first listed.
NCT03211247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03211247 about?
NCT03211247 is a clinical study titled "Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age". The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
What is the current status of trial NCT03211247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 414 participants. The study started on 2017-07-31. Estimated completion is 2022-04-27.
What interventions are being tested in trial NCT03211247?
The interventions under investigation include: Part B Placebo (BIOLOGICAL), Part A Viaskin Peanut 250 mcg (BIOLOGICAL), Part A Viaskin Peanut 100 mcg (BIOLOGICAL), Part A Placebo (BIOLOGICAL), Part B Viaskin Peanut 250 mcg (BIOLOGICAL).
Who is sponsoring clinical trial NCT03211247?
This trial is sponsored by DBV Technologies, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03211247's enrollment target sits among peer trials
414 905th of 2000 higher than 1,096 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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