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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2026-10-12

Brief Summary

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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.

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Detailed Description

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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

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Epidermolysis Bullosa Simplex Ichthyosis Genodermatosis Inflammatory Congenital Ichthyoses

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

challenge dechalenge rechalenge design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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deucravacitinib treatment

challenge-dechallenge -rechallenge design

Group Type EXPERIMENTAL

deucravacitinib

Intervention Type DRUG

treatment by deucravacitinib in two phases of challenge

Interventions

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deucravacitinib

treatment by deucravacitinib in two phases of challenge

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No