EBULO. a 20-Week Multicentre, Open Study Assessing the Efficacy and Safety of Apremilast in Patients > 6 Years of Age with EB Simplex Generalized
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU de Nice
RECRUITING
Nice
APHP Hôpital Saint-Louis
NOT_YET_RECRUITING
Paris
APHP Necker-Enfants-Malades
NOT_YET_RECRUITING
Paris
chu de Toulouse
NOT_YET_RECRUITING
Toulouse
Time Frame
Start Date: 2024-08-06
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 20
Treatments
Experimental: apremilast treatment
treatment by apremilast in two phases of challenge
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice