Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01955109 · ClinicalTrials.gov registry record · Phase 2
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
A Phase 2 study, sponsored by DBV Technologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
NCT01955109: Completed Phase 2 study, sponsored by DBV Technologies.
NCT01955109 is a Phase 2 study that has completed, run by DBV Technologies. The registered enrollment target is 171 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955109, a Phase 2 study, has completed, sponsored by DBV Technologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
Study Summary
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: * To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. * To evaluate the safety of long-term treatment with Viaskin Peanut. * To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.
Primary Outcome
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of ac
Interventions
- BIOLOGICAL Viaskin Peanut 250 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT01955109 record still lists
NCT01955109 is an interventional study that assigns participants to a tested intervention. The registered 171 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 (29% higher).
The record links to 0 conditions, and to 1 intervention - of which Viaskin Peanut 250 mcg is the first listed.
NCT01955109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01955109 about?
NCT01955109 is a clinical study titled "Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children". The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: * To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. * To evaluate the safety of long-term treatment w...
What is the current status of trial NCT01955109?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2013-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01955109?
The interventions under investigation include: Viaskin Peanut 250 mcg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01955109?
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 NCT01955109's enrollment target sits among peer trials
171 398th of 2000 higher than 1,602 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02641145 · 171 participants · NA
Molecular Imaging of Primary Amyloid Cardiomyopathy
- NCT05541029 · 171 participants · NA
Music Listening: A Mechanistic Trial
- NCT05561127 · 171 participants · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
- NCT05592938 · 171 participants · NA
Partial Breast Re-irradiation Using Ultra Hypofractionation (PRESERVE)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia