NCT06136403

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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 study Treatment Period (Period 1); challenge period This period will be the first treatment period that will occur from 16 weeks. During this period the patient will see the doctor at the hospital, he will perform the study procedures The second period : dechallenge (period 2): All patients stop their treatment for 12 weeks. The second treatment period - rechallenge (period 3) the patient will take the treatment for a second 16 weeks period At week 44 - End of study At each visit: The investigator at each visit compliance to the treatment and adverse events, Measure vital signs and perform clinical examination. The patient will assess the different questionnaires, for the study and have blood sample

Conditions

• Epidermolysis Bullosa Simplex
• Ichthyosis
• Genodermatosis
• Inflammatory Congenital Ichthyoses

Interventions

Type	Name	Description
DRUG	deucravacitinib	treatment by deucravacitinib in two phases of challenge

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-09-30
• Completion: 2026-10-12
• First posted: 2023-11-18
• Last updated: 2025-08-05

Locations

2 sites across 1 country: France