Active not recruitingPHASE2INTERVENTIONAL

Vitiligo Treatment by Targeting TYK2 Mediated Responses

Vitiligo is a skin condition that causes white patches. This study is looking at a new medicine called deucravacitinib for treating it. Researchers believe this medicine could help stop vitiligo from getting worse and encourage your skin to re-colour. The study will compare deucravacitinib with a dummy treatment (placebo) first. After a few months, some participants might also receive light therapy (narrowband UVB) alongside the medicine. The main goal is to see how many people show significant improvement in their vitiligo patches after 24 weeks. This research is important because vitiligo can really affect people's lives, and finding better treatments is a key focus.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

128

Start

05 May 2024

Estimated completion

05 Jul 2027

Vitiligo, Generalized

What is this study about?

Vitiligo is a condition where your immune system mistakenly attacks and destroys the colour-making cells (melanocytes) in your skin, leading to white patches. This can affect people's confidence and quality of life. Current treatments aim to either stop the immune attack or encourage these colour-making cells to grow back.

This study is investigating a new medicine called deucravacitinib. Researchers think this medicine can help by calming down the immune system's attack on the skin cells, potentially stopping new white patches from appearing and encouraging existing ones to regain their natural colour. Deucravacitinib has already shown promise in treating another skin condition called psoriasis, and this trial wants to see if it can also be effective and safe for people with vitiligo. Combining this medicine with a type of light therapy (NB-UVB, which uses specific wavelengths of ultraviolet light) might also boost the skin's ability to re-colour.

The main goal of this study is to compare how well deucravacitinib works against a dummy treatment (placebo). They will measure how much vitiligo improves after 24 weeks. Later in the study, they will also look at whether adding narrowband UVB light treatment helps even more. This research is crucial for potentially finding a new and effective way to manage vitiligo.

Key takeaways

This study is testing a new medicine for vitiligo called deucravacitinib.
It aims to see if the medicine helps stop skin patches from growing and encourages skin to re-colour.
Participation involves either the new medicine or a dummy pill initially, then possibly combining the medicine with light therapy.
You'll have regular clinic visits over 48 weeks and might have blood tests and skin samples taken.
This research hopes to find a better treatment for vitiligo, a condition that can affect people's quality of life.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have a type of vitiligo called non-segmental vitiligo. You'll need to have at least one vitiligo patch bigger than 2 square centimetres (not on your face, hands, or feet) and your vitiligo should cover a certain amount of your body. If you are a woman who could become pregnant, you must be using effective contraception for at least a month before joining and throughout the study. You also need to be able to attend all clinic visits and provide your informed consent.

You cannot join if you are pregnant, breastfeeding, or planning to get pregnant during the study. If you have segmental or mixed vitiligo (a different type of vitiligo), or if you are currently using certain medications that affect your immune system, you won't be able to participate. Having certain other medical conditions like skin cancer, active infections, or tuberculosis would also prevent you from joining. This study also excludes people who are participating in other clinical trials that might interfere with its results.

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 an adult between 18 and 75 years old?
Do you have a type of vitiligo called non-segmental vitiligo?
Do you have at least one vitiligo patch not on your face, hands or feet that's bigger than a two-pence coin?
If you could become pregnant, are you using reliable contraception?
Do you not have an active infection or a history of cancer in the last 5 years?
Are you able to attend all study appointments over approximately 11 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be randomly assigned to either receive the study medicine, deucravacitinib (a 12mg tablet once a day), or a dummy treatment (placebo) once a day. This initial part of the study lasts for 24 weeks. After these 24 weeks, you'll be randomly assigned again to either continue with deucravacitinib alone or take deucravacitinib along with light therapy (narrowband UVB) twice a week, for another 24 weeks.

Throughout the study, you will have a total of six visits to the clinic: one to check if you're suitable, another to officially start the study, and then follow-up visits at weeks 12, 24, 36, and 48. At some of these visits, if you agree, small skin samples (biopsies) might be taken from both a vitiligo patch and nearby healthy skin. Blood and urine samples will also be collected at several points during the study to check your health and how the treatment is working. The study will last for a total of 48 weeks (just over 11 months).

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new investigational treatment for your vitiligo that might help stop its spread and encourage re-pigmentation, and you'll receive close medical monitoring. However, there are potential risks, as deucravacitinib is an investigational medicine and could have side effects, which the study will monitor closely. You might also receive a placebo for the first 24 weeks, meaning you wouldn’t get the active drug. As with any medical procedure, there are minor risks associated with blood tests and skin biopsies. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

CHU de Nice - Hôpital de l'Archet
Verified postcode
Nice, France
APHP, Henri Mondor
Verified postcode
Paris, France
CHU de Bordeaux
Verified postcode
Bordeaux, France
CHU de Lille
Verified postcode
Lille, France
HCL
Verified postcode
Lyon, France

Common questions

What is deucravacitinib?

It's a new medicine being tested to see if it can help stop vitiligo from spreading and encourage skin to regain its natural colour.

What is narrowband UVB?

It's a type of light therapy that uses specific wavelengths of ultraviolet light, sometimes used to treat skin conditions like vitiligo.

Will I definitely get the new medicine?

For the first 24 weeks, you'll be randomly assigned to either receive the new medicine or a dummy treatment (placebo).

How long does the study last?

The study lasts for a total of 48 weeks, which is about 11 months, with regular visits to the clinic.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, and your decision will not affect your future medical care.