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RecruitingNCT06136403GENEPIDUpdated Aug 5, 2025

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

A Phase 2 interventional study of deucravacitinib in Epidermolysis Bullosa Simplex, Ichthyosis and Genodermatosis, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 2 sites in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

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

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Keywords

  • deucravacitinib
03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.
  • Infectious/Immune-related Exclusions
  • Medical History and Concurrent Diseases
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    deucravacitinib treatment

    challenge-dechallenge -rechallenge design

    Drug: deucravacitinib

Interventions

  • Drugdeucravacitinib

    treatment by deucravacitinib in two phases of challenge

05

What researchers measure

Primary outcomes

  1. efficacy of deucravacitinib

    number of new blister conting every day

    Time frame: week 44

Secondary outcomes

  1. Safety of deucravacitinib treatment

    record of adverse events

    Time frame: week 44

06

Study locations

2 of 2 sites recruiting
  • CHU de Nice
    Nice, CHU de NICE 06003, France
    • · Contact · 0492034702
    • Christine CHIAVERINI · Principal investigator
    Recruiting
  • APHP St Louis
    Paris, France 75010, France
    • Emmanuelle BOURRAT, Doctor · Contact · marioncauseret@yahoo.fr · 01 42 49 45 41
    • Emmanuelle BOURRAT, Doctor · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06136403
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Mar 18, 2024
Primary completion
Sep 30, 2025 (estimated)
Completion
Oct 12, 2026 (estimated)
Last update
Aug 5, 2025

Study contacts

christine chiaverini
Contact
chiaverini.c@chu-nice.fr
04.92.03.47.02
Christine Chiaverini
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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