Epidermolysis Bullosa SimplexPhase 2GENEPIDNCT06136403
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
A Phase 2 study testing deucravacitinib in people with Epidermolysis Bullosa Simplex and Ichthyosis, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Epidermolysis Bullosa Simplex, Ichthyosis, Genodermatosis
- What is being tested?
- deucravacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Mar 2024to 18 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.
- Infectious/Immune-related Exclusions
- Medical History and Concurrent Diseases
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nice
Nice, CHU de NICE, 06003
APHP St Louis
Paris, France, 75010
About this study
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
- Conditions
- Epidermolysis Bullosa Simplex, Ichthyosis, Genodermatosis, Inflammatory Congenital Ichthyoses
- Being tested
- deucravacitinib
- Keywords
- deucravacitinib
- Medical subject headings
- Epidermolysis Bullosa Simplex, Ichthyosis, Skin Diseases, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deucravacitinibDrug
treatment by deucravacitinib in two phases of challenge
| Study group | Role | What they receive |
|---|---|---|
| deucravacitinib treatment | Experimental | challenge-dechallenge -rechallenge design Receives: Drug: deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of deucravacitinib
number of new blister conting every day
Measured: week 44
Secondary outcomes (1)
Safety of deucravacitinib treatment
record of adverse events
Measured: week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Mar 2024
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis Bullosa SimplexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- challenge dechalenge rechalenge design
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Chiaverini, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136403
- Sponsor's protocol ID
- 22-PP-20
- Other IDs
- 2022-502879-32-00
- Acronym
- GENEPID
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
- ClinicalTrials.gov ID
- NCT06136403
- Acronym / sponsor ID
- GENEPID / 22-PP-20
- Conditions
- Epidermolysis Bullosa Simplex, Ichthyosis, Genodermatosis, Inflammatory Congenital Ichthyoses
- Keywords
- deucravacitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- challenge dechalenge rechalenge design
| Arm | Type | Receives |
|---|---|---|
| deucravacitinib treatment | Experimental | Drug: deucravacitinibchallenge-dechallenge -rechallenge design |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.
- Infectious/Immune-related Exclusions
- Medical History and Concurrent Diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deucravacitinibtreatment by deucravacitinib in two phases of challenge | Drug | deucravacitinib treatment |
Primary outcome
efficacy of deucravacitinib
Time frame: week 44
number of new blister conting every day
1 secondary outcome
Safety of deucravacitinib treatment
Time frame: week 44
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Epidermolysis Bullosa Simplex
RecruitingPhase 2
A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa
Epidermolysis Bullosa (EB), Junctional Epidermolysis Bullosa
RecruitingPhase 2
A Phase II, Placebo Controlled, Clinical Trial of Topical TolaSure Targeting Aggregated Mutant Keratin in Epidermolysis Bullosa Simplex
Epidermolysis Bullosa Simplex
Not yet recruitingPhase 2
Filsuvez in Moderate-to-Severe Epidermolysis Bullosa Simplex
Epidermolysis Bullosa Simplex
Active, not recruitingPhase 2/3
An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)
Generalized Epidermolysis Bullosa Simplex
RecruitingPhase 2
A 20-Week Study Assessing the Efficacy of Apremilast in Patients with EB Simplex Generalized
Epidermolysis Bullosa Simplex, Genodermatosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Chiaverini principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing deucravacitinib in people with Epidermolysis Bullosa Simplex and Ichthyosis, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of deucravacitinib (time frame: week 44). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.