RecruitingPHASE2INTERVENTIONAL

A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses

This study is looking into a new medicine called deucravacitinib for adults who have certain genetic skin conditions. These conditions, like Epidermolysis Bullosa Simplex (EBS) or Ichthyosis, cause skin inflammation, blistering, or very scaly skin from birth. The main goals are to find out how effective this medicine is at treating these conditions and to check for any side effects. It's a study over 44 weeks, where participants will take the medicine, stop for a period, and then restart it. Regular hospital visits will be needed for health checks and blood tests.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

18 Mar 2024

Estimated completion

12 Oct 2026

Epidermolysis Bullosa Simplex Ichthyosis Genodermatosis Inflammatory Congenital Ichthyoses

What is this study about?

This research study is investigating a new medication called deucravacitinib. It's designed for adult patients who have certain genetic skin conditions that cause ongoing inflammation. These conditions include specific types of Epidermolysis Bullosa Simplex (EBS), which leads to very fragile skin and blisters, and various forms of Ichthyosis, which can cause thick, scaly, and inflamed skin right from birth. The main purpose of this study is to understand how well deucravacitinib works in improving or managing these skin issues, and just as importantly, to check if it's safe for people to use.

This is a 'Phase 2' trial, meaning the medicine has already passed initial safety tests and is now being studied more closely in a small group of patients to see if it has a positive effect. By taking part, you would be helping doctors and researchers learn more about how to treat these challenging conditions, potentially leading to better options for patients in the future.

The study involves carefully checking your health, giving you the study medicine, and then closely watching how your body responds. It's organised over 44 weeks and includes different periods where you'll be taking the medicine, then having a break from it, and then restarting it. Your involvement is crucial for gathering important information.

Key takeaways

This study is for adults with specific types of Epidermolysis Bullosa Simplex (EBS) or Ichthyosis.
It's testing a new medicine called deucravacitinib over 44 weeks.
Participation involves taking the medicine, a break, and then restarting it, with 8 hospital visits.
The main goals are to find out if the medicine is effective and safe.
You will have regular health checks, blood tests, and fill out questionnaires.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 99 years old. You must have a specific type of genetic skin condition, either Epidermolysis Bullosa Simplex (EBS) with severe blistering, confirmed by genetic testing, or an inflammatory type of Ichthyosis, also confirmed by genetic testing.

Your skin condition needs to be active enough to be studied. For those with EBS, you should typically be getting at least four new blisters every day. For those with Ichthyosis, your skin symptoms need to reach a certain level of severity as measured by doctors.

There are also some reasons why you might not be able to join. For example, if you have other types of Ichthyosis not covered by this study (like Netherton syndrome), or if you have certain infections, immune problems, or health conditions that could interfere with the study or make the medicine unsafe for you. The study team will review all your medical information carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged between 18 and 99 years old?
Do you have a genetically confirmed diagnosis of severe Epidermolysis Bullosa Simplex (EBS) or an inflammatory type of Ichthyosis?
For EBS, do you usually get at least 4 new blisters daily? Or for Ichthyosis, has your doctor said your condition is severe?
Are you able to attend 8 hospital visits over 44 weeks?
Are you willing to avoid using any skin treatments during the study that aren't approved by the study doctors?
Do you not have certain other specific health conditions or infections that would prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for a total of 44 weeks. You'll have eight planned visits to the hospital. Before officially joining, the study team will explain everything in detail and make sure you meet all the criteria. Once you agree, you'll sign a consent form.

The study is split into three main periods. For the first 16 weeks, you'll be taking the study medicine. During this time, you'll have doctor's appointments where your health will be checked, your vital signs (like blood pressure) will be measured, and doctors will examine your skin. You'll also fill out questionnaires about your condition and provide blood samples.

After this, there will be a 12-week 'dechallenge' period where you will stop taking the medicine. Following this, you'll start taking the medicine again for another 16-week period. At each visit, the study team will check how you're getting on with the medicine and look for any side effects.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new treatment that could help manage your skin condition, which isn't yet widely available. However, there's no guarantee the medicine will work for you. Like all medications, deucravacitinib could have side effects, which the study team will monitor closely. You'll be told about known potential risks during the consent process. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

CHU de Nice
Verified postcode
Nice, France· Recruiting
APHP St Louis
Verified postcode
Paris, France· Recruiting

Common questions

What is deucravacitinib?

It's a new medicine being tested to see if it can help adults with certain inflammatory genetic skin conditions.

How long does the study last?

The entire study will last for 44 weeks, which is about 10 months.

How many times do I need to visit the hospital?

You will have 8 hospital visits throughout the 44-week study period.

Will I always be taking the medicine?

No, you will take the medicine for 16 weeks, then stop for 12 weeks, and then take it again for another 16 weeks.

Who can I talk to if I have more questions?

You should speak to your doctor or the study team, who can provide more detailed information.

How to find out more

christine chiaverini

chiaverini.c@chu-nice.fr 04.92.03.47.02 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.