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NCT01675882 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
A Phase 2 study, sponsored by DBV Technologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 221
- Enrollment target
NCT01675882: Completed Phase 2 study, sponsored by DBV Technologies.
NCT01675882 is a Phase 2 study that has completed, run by DBV Technologies. The registered enrollment target is 221 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675882, a Phase 2 study, has completed, sponsored by DBV Technologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 221 participants
- Enrollment target
Study Summary
The objectives of this dose-finding study for the treatment of peanut allergy are: * To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. * To evaluate the safety of a long-term treatment with Viaskin Peanut.
Primary Outcome
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).
Interventions
- BIOLOGICAL Viaskin Peanut 250 mcg
- BIOLOGICAL Viaskin Placebo
- BIOLOGICAL Viaskin Peanut 50 mcg
- BIOLOGICAL Viaskin Peanut 100 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01675882 record still lists
NCT01675882 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% higher).
The record links to 0 conditions, and to 4 interventions - of which Viaskin Peanut 250 mcg is the first listed.
NCT01675882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01675882 about?
NCT01675882 is a clinical study titled "Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy". The objectives of this dose-finding study for the treatment of peanut allergy are: * To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. * To evalu...
What is the current status of trial NCT01675882?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 221 participants. The study started on 2012-08. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01675882?
The interventions under investigation include: Viaskin Peanut 250 mcg (BIOLOGICAL), Viaskin Placebo (BIOLOGICAL), Viaskin Peanut 50 mcg (BIOLOGICAL), Viaskin Peanut 100 mcg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01675882?
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 NCT01675882's enrollment target sits among peer trials
221 275th of 2000 higher than 1,726 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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