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GENEPID: A 44-weeks monocentric open study assessing the efficacy and safety of Deucravacitinib in adults with Inflammatory EPidermal GENodermatoses
EU CTIS ID: 2022-502879-32-00
What this study is testing
To describe efficacy of deucravacitinib over the 3 periods of a challenge-dechallenge-rechallenge design like study in adults with inflammatory congenital ichthyosis (ICI) erythrodermic congenital ichtyosis (CEI) /severe keratinopathic ichtyosis (KI) or severe simplex EB (EBS-sev).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient > 18 years of both sexes
- Patient with a laboratory confirmed diagnosis of EBS due to KRT5 or 14 mutation or CIE or with KI due to KR1 orKRT10 mutation
You likely can't join if
- Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc
- Infectious/Immune-related Exclusions
- Medical History and Concurrent Diseases
- Subject has another member of her/his immediate family (i.e., living in the same household) enrolled in this study.
- Subject has used any diacerein containing product within 6 months prior to Visit 1.
- Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit 1
See the full eligibility criteria
- Patient > 18 years of both sexes
- Patient with a laboratory confirmed diagnosis of EBS due to KRT5 or 14 mutation or CIE or with KI due to KR1 orKRT10 mutation
- Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc
- Infectious/Immune-related Exclusions
- Medical History and Concurrent Diseases
- Subject has another member of her/his immediate family (i.e., living in the same household) enrolled in this study.
- Subject has used any diacerein containing product within 6 months prior to Visit 1.
- Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Visit 1
- Subject has used systemic steroidal therapy within 30 days prior to Visit 1.
- Subject has used any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study assessments within 30 days prior to Visit 1.
- Subject has a history of sensitivity to any of the ingredients of deucravacitinib.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.