A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

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 safety of this treatment.

Participants will take treatments and have to use bullets during the study period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Deucravacitinib

Criteria

Inclusion Criteria:

• 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 Criteria:

• Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.

• Infectious/Immune-related Exclusions

• Medical History and Concurrent Diseases