Status:
RECRUITING
A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Epidermolysis Bullosa Simplex
Genodermatosis
Eligibility:
All Genders
6-99 years
Phase:
PHASE2
Brief 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 effi...
Detailed Description
The patient will have 7 visits. After Confirmation of inclusion criteria and no exclusion criteria, the study will be explain to the patient after signing the inform consent and be included in the stu...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06509984
Start Date
August 6 2024
End Date
April 1 2026
Last Update
February 24 2025
Active Locations (4)
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1
CHU de Nice
Nice, France, France, 06000
2
APHP Necker-Enfants-Malades
Paris, France, France, 75015
3
APHP Hôpital Saint-Louis
Paris, France, France, 75018
4
chu de Toulouse
Toulouse, France, 31059