A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
EBULO. a 20-Week Multicentre, Open Study Assessing the Efficacy and Safety of Apremilast in Patients > 6 Years of Age with EB Simplex Generalized
Centre Hospitalier Universitaire de Nice
20 participants
Aug 6, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to Assessing the Efficacy and Safety of Apremilast in Patients \> 6 years of age with EB simplex generalized . The main question it aims to answer are: describe efficacity of this treatment. Participants will take treatments and have to use bullets during the study period.
Eligibility
Inclusion Criteria4
- Male or female patients 6 years or older
- Laboratory confirmed diagnosis of EBS-sev due to KRT5 or 14 mutation (autosomal)
- Mean daily number of new blisters >3.
- Subject/caregiver agrees not to use any topical therapies other than the investigator approved
Exclusion Criteria5
- \- EBS lesions requiring oral therapy to treat an infection
- Use of any diacerein containing product within 6 months prior to Visit 1
- Use of systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit 1
- Use of systemic steroidal therapy within 30 days prior to Visit 1
- Use of any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study assessments within 30 days prior to Visit 1
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
treatment of apremilast
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06509984