Study on the Effects of Deucravacitinib for Adults with Inflammatory Skin Conditions (Epidermolysis Bullosa Simplex and Congenital Ichthyoses)

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What is this study about?

This clinical trial is focused on studying the effects of a medication called deucravacitinib in adults with certain skin conditions known as inflammatory epidermal genodermatoses. These conditions include epidermolysis bullosa simplex and inflammatory congenital ichthyoses. The purpose of the study is to evaluate how effective and safe deucravacitinib is for treating these skin conditions.

Participants in the study will take deucravacitinib, which is provided in the form of a 6 mg film-coated tablet, taken orally. The study will last for 44 weeks and will follow a specific pattern where the medication is given, then stopped, and then given again. This approach helps researchers understand how the medication works over time. The study will also look at how the medication affects the severity of the skin conditions, the level of itch and pain experienced, and the overall quality of life of the participants.

Throughout the study, the safety of deucravacitinib will be closely monitored. Researchers will also collect information on how well participants follow the treatment plan and will analyze certain proteins in the body, known as cytokines, to understand their role in these skin conditions. The study aims to provide valuable insights into the potential benefits of deucravacitinib for people living with these challenging skin disorders.

1 introduction to the study

Upon joining the study, the patient will receive an overview of the trial’s purpose, which is to assess the effectiveness and safety of deucravacitinib in treating inflammatory epidermal genodermatoses.

The study is designed to last for 44 weeks and involves a challenge-dechallenge-rechallenge approach.

2 medication administration

The patient will be administered deucravacitinib, which is a 6 mg film-coated tablet taken orally.

The specific dosage schedule and frequency will be provided by the study team, ensuring the patient understands how to take the medication correctly.

3 monitoring and assessments

Throughout the study, the patient will undergo regular assessments to monitor the efficacy and safety of the treatment.

These assessments will include evaluations of skin condition severity, itch, pain, and overall quality of life.

Additional tests may include baseline and functional cytokine profile analysis to understand the body’s response to the treatment.

4 safety evaluations

Safety is a primary concern, and the patient will be closely monitored for any adverse effects related to the medication.

Regular check-ins with the study team will ensure any concerns are addressed promptly.

5 completion of the study

At the end of the 44-week period, the patient will have a final evaluation to assess the overall outcomes of the treatment.

The study aims to provide valuable insights into the treatment’s effectiveness and impact on the patient’s condition.

Who Can Join the Study?

The patient must be over 18 years old.
The patient can be of any gender.
The patient must have a confirmed diagnosis through laboratory tests of one of the following conditions:
- EBS (Epidermolysis Bullosa Simplex) due to a mutation in the KRT5 or KRT14 genes. These are specific genes related to skin conditions.
- CIE (Congenital Ichthyosiform Erythroderma), a type of skin disorder.
- KI (Keratinopathic Ichthyosis) due to a mutation in the KRT1 or KRT10 genes. These are also specific genes related to skin conditions.

Who Cannot Join the Study?

Individuals who do not have the specific skin conditions being studied, such as inflammatory congenital ichthyosis, erythrodermic congenital ichthyosis, severe keratinopathic ichthyosis, or severe simplex EB, cannot participate.
People who are not within the specified age range for the study are excluded. The study is for adults only.
Participants who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Deucravacitinib

Deucravacitinib is a medication being studied for its effectiveness and safety in treating certain skin conditions known as inflammatory epidermal genodermatoses. These conditions include epidermolysis bullosa simplex and inflammatory congenital ichthyoses. The trial aims to see how well this medication works over different periods in a study design that involves starting, stopping, and then restarting the treatment.

Investigated diseases:

Epidermolysis bullosa

Inflammatory Epidermal Genodermatoses – This is a group of rare genetic skin disorders characterized by chronic inflammation and abnormal skin development. These conditions often result in thickened, scaly skin and can cause significant discomfort due to itching and pain. The skin may appear red and inflamed, and the severity can vary widely among individuals. These disorders are typically present from birth and can affect the skin’s ability to function properly. Over time, the skin may become more prone to infections and other complications due to its compromised barrier function. The progression of symptoms can fluctuate, with periods of worsening and improvement.

Trial ID:

2022-502879-32-00

Protocol code:

22-PP-20

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Deucravacitinib for Adults with Inflammatory Skin Conditions (Epidermolysis Bullosa Simplex and Congenital Ichthyoses)

What is this study about?

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