Trials / Unknown
UnknownNCT03013517
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- DBV Technologies · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Viaskin Peanut 250µg | DBV712 250 µg, once daily |
Timeline
- Start date
- 2017-01-23
- Primary completion
- 2019-11-23
- Completion
- 2023-03-01
- First posted
- 2017-01-06
- Last updated
- 2020-12-02
Locations
31 sites across 5 countries: United States, Australia, Canada, Germany, Ireland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03013517. Inclusion in this directory is not an endorsement.