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

NCT06136403 | Recruiting Phase 2

• 2 other identifiers: 22-PP-202022-502879-32-00
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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 safety of this treatment. Participants will take treatments and have to use bullets during the study period.

Conditions

Epidermolysis Bullosa Simplex; Ichthyosis; Genodermatosis; Inflammatory Congenital Ichthyoses

Keywords

deucravacitinib

Outcome Measures

Primary Outcomes (1)

• efficacy of deucravacitinib

  number of new blister conting every day

  week 44

Secondary Outcomes (1)

• Safety of deucravacitinib treatment

  week 44

Study Arms (1)

deucravacitinib treatment

EXPERIMENTAL

challenge-dechallenge -rechallenge design

Drug: deucravacitinib

Interventions

deucravacitinib DRUG

treatment by deucravacitinib in two phases of challenge

deucravacitinib treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.
• Medical History and Concurrent Diseases

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice

Nice, CHU de NICE, 06003, France

RECRUITING

APHP St Louis

Paris, France, 75010, France

RECRUITING

MeSH Terms

Conditions

Epidermolysis Bullosa Simplex; Ichthyosis; Skin Diseases, Genetic

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Infant, Newborn, Diseases; Keratosis

Study Officials

• Christine Chiaverini

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

christine chiaverini

CONTACT

04.92.03.47.02; chiaverini.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: challenge dechalenge rechalenge design

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: March 18, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): October 12, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)