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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU de Nice
RECRUITING
Nice
APHP St Louis
RECRUITING
Paris
Contact Information
Primary
christine chiaverini
chiaverini.c@chu-nice.fr
04.92.03.47.02
Time Frame
Start Date: 2024-03-18
Estimated Completion Date: 2026-10-12
Participants
Target number of participants: 10
Treatments
Experimental: deucravacitinib treatment
challenge-dechallenge -rechallenge design
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov