Active not recruitingPHASE3INTERVENTIONAL

A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo

This study is investigating a new tablet medicine called upadacitinib for adults and teenagers who have non-segmental vitiligo, a condition where the body's immune system mistakenly attacks skin cells that produce colour. Researchers want to find out how safe upadacitinib is and how well it works to improve the skin's appearance compared to a dummy pill (placebo) or a type of light therapy. The study involves different stages, with some participants receiving upadacitinib and others receiving a placebo at first. Later on, everyone will receive upadacitinib. There are also optional parts that combine the tablet with light therapy or look at different doses. The aim is to see if upadacitinib can help improve vitiligo symptoms.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

614

Start

19 Dec 2023

Estimated completion

01 Mar 2028

Vitiligo

What is this study about?

This research study is about a condition called vitiligo, where patches of skin lose their colour because the body's own immune system attacks the cells that make pigment. It's a common condition, and this study focuses on a specific type called non-segmental vitiligo. The main goal is to test a new tablet medicine called upadacitinib. Researchers want to understand if this medicine is safe to use and how effective it is at helping the skin get its colour back or stop the condition from getting worse.

The study is quite detailed and has several parts. In the main parts, some participants will receive the active medicine (upadacitinib) and others will get a 'dummy' pill called a placebo. This helps researchers compare the effects of the actual medicine. There's about a 1 in 3 chance of getting the placebo at the start. Later in the study, everyone will get the upadacitinib tablet. There are also optional parts, including one that looks at combining the tablet with a type of light therapy called NB-UVB, and another that explores different doses of the medicine.

This study is important because it could lead to new ways to help people living with vitiligo. By carefully watching how participants respond to upadacitinib, and noting any effects, good or bad, the researchers can learn more about its potential. The information gathered will be used to help decide if upadacitinib could become a new treatment option for vitiligo in the future.

Key takeaways

This study is testing a new tablet medicine for non-segmental vitiligo.
It involves adults and teenagers aged 12 and over.
Some participants will receive a dummy pill (placebo) at first, then everyone gets the active medicine.
The study aims to check how safe and effective the medicine is.
Participation involves regular clinic visits for checks, blood tests, and questionnaires.
There are optional parts, including light therapy, for some participants.

Who may be eligible?

To join this study, adults and teenagers (12 years and older) must have been diagnosed with non-segmental vitiligo. Doctors will check your skin to make sure the vitiligo is active enough to be included in the study.

You might be able to take part if you have vitiligo covering a certain amount of your body, and you've either not responded to other skin creams or have signs that your vitiligo is getting worse.

You cannot join the study if you have a different type of vitiligo called segmental vitiligo, or if you have other skin conditions that might make it hard for doctors to properly assess your vitiligo. Also, if too much of the hair in your vitiligo patches has turned white, you might not be suitable for this particular study.

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.

I am 12 years old or older.
I have been diagnosed with non-segmental vitiligo.
My vitiligo covers enough of my skin to meet the study's requirements.
I don't have segmental vitiligo or another skin condition that might interfere.
Most of the hair in my vitiligo patches has not turned white.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of around 540 people worldwide joining this study. You'll need to visit a hospital or clinic regularly for check-ups. These visits will involve medical assessments, blood tests, checks for any side effects, and filling out questionnaires about your health and how you're feeling.

The study involves taking upadacitinib tablets (or a dummy pill at the start) once a day. The length of time you'll be taking the study medicine varies depending on which part of the study you're in, but it could be for many months, even over a year. After you stop taking the study medicine, you'll have a follow-up visit about 30 days later.

Some parts of the study might involve more frequent visits or different treatments, like light therapy, in addition to the tablets. The study is designed to carefully monitor your health and the effects of the treatment throughout the whole period.

Potential risks and benefits

Taking part in a clinical trial like this can offer potential benefits, such as access to a new investigational medicine that might help your vitiligo. However, there are also potential risks, as upadacitinib is still being studied and its full effects are not yet known. Like all medicines, it could have side effects. Compared to your usual care, taking part in this study might mean more hospital visits and procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (148)

Advanced Research Associates - Glendale /ID# 259915
Verified postcode
Glendale, United States
Alliance Dermatology and Mohs Center /ID# 259926
Verified postcode
Phoenix, United States
Private Practice - Dr. Tooraj Raoof /ID# 260055
Verified postcode
Encino, United States
University of California Irvine /ID# 260080
Verified postcode
Irvine, United States
Vitiligo & Pigmentation Institute of Southern California /ID# 259970
Verified postcode
Los Angeles, United States
Dermatology Research Associates /ID# 260056
Verified postcode
Los Angeles, United States
Duplicate_Stanford University /ID# 260081
Verified postcode
Redwood City, United States
Integrative Skin Science and Research /ID# 260060
Verified postcode
Sacramento, United States
University of California Davis Health /ID# 260062
Verified postcode
Sacramento, United States
Clinical Trials Research Institute /ID# 259910
Verified postcode
Thousand Oaks, United States
Skin Care Research Boca Raton /ID# 260094
Verified postcode
Boca Raton, United States
Apex Clinical Trials /ID# 260096
Verified postcode
Brandon, United States

Common questions

What is vitiligo?

Vitiligo is a long-term skin condition where patches of your skin lose their natural colour, leaving white or lighter areas. It happens when cells that make skin pigment stop working.

What is Upadacitinib?

Upadacitinib is a new tablet medicine being tested to see if it can help improve vitiligo by calming the overactive immune system that causes the condition.

What is a 'placebo' in a study?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers see if the real medicine actually works better than no treatment at all.

Will I get light therapy?

Some parts of the study offer narrow-band ultraviolet B (NB-UVB) light therapy as an option, either on its own or with upadacitinib, but it's not for everyone in the study.

What does 'Phase 3' mean for a study?

Phase 3 means the medicine has already passed earlier safety checks and is now being tested on a larger group of people to confirm its effectiveness and monitor side effects before it can be approved for general use.