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CompletedNCT06136403GENEPIDUpdated Oct 16, 2026

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. Completed at 2 sites in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

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

Updated Oct 16, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
8
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

Keywords

  • deucravacitinib
03

In context

Epidermolysis Bullosa Simplex

20 studies on the registry are indexed under Epidermolysis Bullosa Simplex; 5 are open to participants now.

This study's enrollment of 8 is below the median of 19 across 17 interventional studies indexed under Epidermolysis Bullosa Simplex.

Browse Epidermolysis Bullosa Simplex studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

Study design

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

Study arms

  • Experimental
    deucravacitinib treatment

    challenge-dechallenge -rechallenge design

    Drug: deucravacitinib

Interventions

06

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

07

Study locations

2 sites
  • CHU de Nice
    Nice, CHU de NICE 06003, France
  • APHP St Louis
    Paris, France 75010, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 16, 2026
Primary completion
Sep 30, 2025→Aug 18, 2026 (actual)
Oct 16, 2026
Study completion
Oct 12, 2026→Aug 18, 2026 (actual)
Oct 16, 2026
Enrollment
10 (estimated)→8 (actual)
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Recruiting→Completed
    Primary completion Sep 30, 2025→Aug 18, 2026 (now actual)
    Study completion Oct 12, 2026→Aug 18, 2026 (now actual)
    Enrollment 10 (estimated)→8 (actual)
    + 4 other changes: verification date, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06136403
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Mar 18, 2024
Primary completion
Aug 18, 2026
Completion
Aug 18, 2026
Last update
Oct 16, 2026

Study contacts

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 ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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