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NCT01904604 · ClinicalTrials.gov registry record · Phase 2
Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT01904604: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01904604 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904604, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.
Primary Outcome
Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.
Interventions
- BIOLOGICAL Placebo Viaskin® Patch
- BIOLOGICAL Low-dose DBV712 Viaskin® Patch
- BIOLOGICAL High-dose DBV712 Viaskin® Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-08-21 |
| Phase | Phase 2 |
What the finished NCT01904604 record still lists
NCT01904604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo Viaskin® Patch is the first listed.
NCT01904604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01904604 about?
NCT01904604 is a clinical study titled "Peanut Epicutaneous Phase II Immunotherapy Clinical Trial". Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy...
What is the current status of trial NCT01904604?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2013-09. Estimated completion is 2018-08-21.
What interventions are being tested in trial NCT01904604?
The interventions under investigation include: Placebo Viaskin® Patch (BIOLOGICAL), Low-dose DBV712 Viaskin® Patch (BIOLOGICAL), High-dose DBV712 Viaskin® Patch (BIOLOGICAL).
Who is sponsoring clinical trial NCT01904604?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01904604's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 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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