Status:
RECRUITING
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Epidermolysis Bullosa Simplex
Ichthyosis
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to learn about deucravacitinib treatment in adults with inflammatory epidermal genodermatoses . The main question it aims to answer are: describe efficacity and safe...
Detailed Description
The patient will have 8 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 stud...
Eligibility Criteria
Inclusion
- Subject has congenital skin fragility with skin and/or mucosal blisters, a clinical phenotype of EBS-sev and a laboratory confirmed diagnosis of EBS by KRT5 and/or 14 mutation (autosomal only) OR a clinical phenotype of inflammatory ichthyosis (IC) including keratinopathic ichthyosis due to KRT1/10 mutation, ECI with identified genetic mutations (TGM5, NIPAL4, ABCA12, etc…).
- Subject has at least a mean daily number of 4 new blisters (EBS-sev) OR an ISS \> 50/128.
- Subject agrees not to use any topical therapies other than the investigator approved.
Exclusion
- Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.
- Infectious/Immune-related Exclusions
- Medical History and Concurrent Diseases
Key Trial Info
Start Date :
March 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 12 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06136403
Start Date
March 18 2024
End Date
October 12 2026
Last Update
August 5 2025
Active Locations (2)
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1
CHU de Nice
Nice, CHU de NICE, France, 06003
2
APHP St Louis
Paris, France, France, 75010