Evaluating the effects of deucravacitinib in adults with inflammatory skin conditions
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
This study is testing a new medication called deucravacitinib to see if it can help adults with certain inflammatory skin conditions feel better and improve their skin health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | deucravacitinib |
| Locations | 2 sites (Nice, CHU de NICE and 1 other locations) |
| Trial ID | NCT06136403 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of deucravacitinib in adults suffering from inflammatory genodermatoses, specifically targeting conditions like Epidermolysis Bullosa Simplex and Ichthyosis. Participants will undergo a structured treatment regimen over 44 weeks, which includes an initial treatment period, a dechallenge phase where treatment is paused, and a rechallenge phase. Throughout the study, patients will have regular visits to monitor compliance, adverse events, and overall health through clinical examinations and questionnaires. Blood samples will also be collected to evaluate treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of severe Epidermolysis Bullosa Simplex or inflammatory ichthyosis, experiencing a high frequency of skin blistering.
Not a fit: Patients with other forms of ichthyosis or those with infectious or immune-related exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with severe inflammatory skin conditions.
How similar studies have performed: While this specific approach with deucravacitinib is novel, similar studies targeting inflammatory skin conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nice, CHU de NICE and 1 other locations
- CHU de Nice — Nice, CHU de NICE, France (Recruiting)
- APHP St Louis — Paris, France, France (Recruiting)
Study contacts
- Principal investigator: Christine Chiaverini — Centre Hospitalier Universitaire de Nice
- Study coordinator: christine chiaverini
- Email: chiaverini.c@chu-nice.fr
- Phone: 04.92.03.47.02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.