Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02223182 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
A Phase 1 study, sponsored by DBV Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 198
- Enrollment target
NCT02223182: Completed Phase 1 study, sponsored by DBV Technologies.
NCT02223182 is a Phase 1 study that has completed, run by DBV Technologies. The registered enrollment target is 198 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (230% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02223182, a Phase 1 study, has completed, sponsored by DBV Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 198 participants
- Enrollment target
Study Summary
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.
Primary Outcome
A treatment responder is defined as a subject who meets at least one of the following criteria: * A ≥10-fold increase in the Cumulative Reactive Dose (CRD) of cow's milk proteins at the Month 12 double-blind placebo-controlled food challenge (DBPCFC) as compared to baseline value and reaching at least 144 mg of cow's milk proteins; * A CRD of cow's milk proteins ≥1444 mg at the Month 12 DBPCFC.
Interventions
- BIOLOGICAL Viaskin Milk 150 mcg
- BIOLOGICAL Viaskin Milk 300 mcg
- BIOLOGICAL Viaskin Milk 500 mcg
- BIOLOGICAL Viaskin Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2014-11 |
| Est. Completion | 2020-12-22 |
| Phase | Phase 1 |
What the finished NCT02223182 record still lists
NCT02223182 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (230% higher).
The record links to 0 conditions, and to 4 interventions - of which Viaskin Milk 150 mcg is the first listed.
NCT02223182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02223182 about?
NCT02223182 is a clinical study titled "Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy". The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the long-term safety and therapeutic benefit with Viaskin Milk.
What is the current status of trial NCT02223182?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 198 participants. The study started on 2014-11. Estimated completion is 2020-12-22.
What interventions are being tested in trial NCT02223182?
The interventions under investigation include: Viaskin Milk 150 mcg (BIOLOGICAL), Viaskin Milk 300 mcg (BIOLOGICAL), Viaskin Milk 500 mcg (BIOLOGICAL), Viaskin Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT02223182?
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 NCT02223182's enrollment target sits among peer trials
198 277th of 2000 higher than 1,723 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
- NCT05203328 · 198 participants · NA
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
- NCT05426967 · 198 participants · NA
rTMS for Military TBI-related Depression
- NCT05561114 · 198 participants · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
- NCT05585190 · 198 participants · NA
Stand Up for Your Health with a Sit-stand Desk
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