Actively Recruiting
A 44-week Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-08-05
10
Participants Needed
2
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the treatment of deucravacitinib in adults with inflammatory epidermal genodermatoses, including conditions such as Epidermolysis Bullosa Simplex and various ichthyoses. The study focuses on assessing the efficacy and safety of this treatment for these rare skin disorders. It is a phase 2, open-label trial lasting 44 weeks conducted at a single center. Participants will undergo a treatment schedule divided into three periods: an initial 16-week treatment (challenge period), followed by a 12-week break from treatment (dechallenge period), and a second 16-week treatment period (rechallenge period). During these phases, participants will receive deucravacitinib and be closely monitored. The study uses a challenge-dechallenge-rechallenge design to evaluate treatment effects. Throughout the study, participants will attend eight visits where doctors will check their vital signs, perform clinical exams, and assess treatment adherence and any side effects. Participants will also complete questionnaires and provide blood samples. Researchers will primarily measure the efficacy of deucravacitinib at week 44 and monitor safety. The total participation duration is 44 weeks, ending with a final evaluation.
CONDITIONS
Brief Title
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 99 years
- Diagnosis of congenital skin fragility with skin or mucosal blisters confirmed by genetic testing for specific mutations related to Epidermolysis Bullosa Simplex or inflammatory ichthyosis
- At least 4 new blisters daily or an Ichthyosis Severity Score above 50
- Agreement to avoid using topical therapies not approved by the investigator
You will not qualify if you...
- Presence of other forms of inflammatory congenital ichthyosis such as Netherton syndrome or KID syndrome
- Infectious or immune-related medical conditions
- Certain medical history or concurrent diseases that may interfere with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive deucravacitinib treatment during the first 16-week challenge period with regular hospital visits for study procedures.
Multiple visits during 16 weeks for treatment assessments
Duration - 12 weeks
Participants stop treatment during the 12-week dechallenge period without active medication.
Visits for assessments during treatment pause
Duration - 16 weeks
Participants receive deucravacitinib again during the 16-week rechallenge period with hospital visits for study procedures.
Multiple visits during 16 weeks for treatment assessments
Trial Site Locations
Total: 2 locations
1
CHU de Nice
Nice, CHU de NICE, France, 06003
Actively Recruiting
2
APHP St Louis
Paris, France, France, 75010
Actively Recruiting
Research Team
C
christine chiaverini
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here