Active not recruitingPHASE3INTERVENTIONAL

A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo

This study is exploring a medicine called ritlecitinib for non-segmental vitiligo, a condition where people develop white patches on their skin. The main goal is to see how safe the medicine is and how well it works. This study focuses on people who have already taken part in an earlier study with ritlecitinib or a dummy pill (placebo). Researchers want to find out if the improvements they saw in the first study last, if taking a higher dose helps more, or how long improvements last if they switch to a dummy pill. Everyone in this study will take either ritlecitinib or a placebo capsule every day for up to 52 weeks to understand its long-term effects on vitiligo.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

394

Start

19 Jan 2024

Estimated completion

31 Mar 2027

Vitiligo

What is this study about?

Vitiligo is a long-term skin condition where white patches appear on your skin because the cells that give your skin its colour stop working. This study is specifically for non-segmental vitiligo, which is a particular type where these patches often appear on both sides of the body and can spread. It's thought to be an 'autoimmune' condition, meaning your body's immune system mistakenly attacks its own healthy cells.

This study wants to learn more about a medicine called ritlecitinib. We already know a bit about ritlecitinib because it's approved for treating a similar condition called severe alopecia areata, which also involves your body's immune system. By looking at how ritlecitinib works and how safe it is over a longer period, doctors hope to find out if it's a good treatment option for people living with non-segmental vitiligo.

The main aim of this research is to see if the skin colour that returned in a previous study with ritlecitinib stays there, or even improves further, with continued treatment. They also want to know if a higher dose (100 milligrams) might be more effective, or how long any improvements last if someone stops the active medicine and switches to a dummy pill (placebo). This will help doctors understand the best way to use ritlecitinib for vitiligo in the future.

Key takeaways

This study is for people who have already taken part in a previous vitiligo study (B7981040).
It aims to understand the long-term safety and effectiveness of ritlecitinib for non-segmental vitiligo.
Participants will take ritlecitinib or a placebo (dummy pill) every day for up to 52 weeks.
The study looks at whether skin colour that returned stays the same, increases with a higher dose, or how long it lasts.
You will have 9 clinic visits over a maximum of 60 weeks.
Ritlecitinib is already approved for a similar condition in some countries.

Who may be eligible?

To be able to join this study, you need to have already taken part in a previous vitiligo study (called B7981040) and have completed 52 weeks of that study. You must have also met all the requirements to join that first study, whether you had vitiligo that was getting worse or was stable.

Another important requirement is your age. You must have been at least 18 years old when you started the first study. Young people aged 12 to under 18 might also be able to join, but this depends on approval from local health and ethics committees.

Finally, you cannot join this study if you had to stop the previous study because of a safety concern, or if you have any serious health problems or thoughts of harming yourself that could make taking part unsafe.

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.

Did I complete 52 weeks of the previous vitiligo study (B7981040)?
Was I at least 18 years old when I started the previous study (or 12-17 with special approval)?
Did I have non-segmental vitiligo in the previous study?
Did I *not* have to stop the previous study because of a safety issue?
Do I currently have no active thoughts of harming myself or serious health problems that make study participation unsafe?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be involved for a maximum of 60 weeks, which is about 14 months. During this time, you'll have 9 visits to the study clinic. You will be taking either the study medicine (ritlecitinib 50 mg or 100 mg) or a dummy pill (placebo) as capsules by mouth every day.

Most days, you'll take your study medicine at home. However, on the days you have a study visit, you'll be asked to take your capsule at the clinic. You could be receiving the study medicine or placebo for up to 52 weeks of the study. The researchers will be closely monitoring your health and how the medicine affects your vitiligo throughout this period.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit here is that ritlecitinib might help your white patches regain colour, and your participation helps researchers learn more about vitiligo which could help others in the future. However, there's no guarantee the medicine will work for you, and like all medicines, ritlecitinib can have side effects. Some people in the study will also receive a placebo, which means they won't get the active medicine. You will be closely monitored by medical staff throughout the study, and you always have the right to withdraw from the study at any time without giving a reason, which will not affect your usual medical care.

Locations (73)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

California Dermatology & Clinical Research Institute
Verified postcode
Encinitas, United States
Marvel Clinical Research
Verified postcode
Huntington Beach, United States
Wallace Medical Group, Inc
Verified postcode
Los Angeles, United States
Encore Medical Research of Boynton Beach
Verified postcode
Boynton Beach, United States
Skin Care Research
Verified postcode
Hollywood, United States
ForCare Clinical Research
Verified postcode
Tampa, United States
Dawes Fretzin Clinical Research Group, LLC
Verified postcode
Indianapolis, United States
DelRicht Research
Verified postcode
Baton Rouge, United States
Lawrence J. Green, MD LLC
Verified postcode
Rockville, United States
University of Michigan
Verified postcode
Ann Arbor, United States
University of New Mexico Health Sciences Center
Verified postcode
Albuquerque, United States
SUNY Downstate Health Sciences University
Verified postcode
Brooklyn, United States

Common questions

What is vitiligo?

Vitiligo is a long-term skin condition where patches of your skin lose their colour and turn white. This happens because the cells that produce skin pigment stop working properly.

What is ritlecitinib?

Ritlecitinib is a medicine being studied for vitiligo. It's already approved in some areas for a different autoimmune condition called severe alopecia areata, which is similar in how it affects the body.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers compare the effects of the active medicine against no treatment.

How long will I take part in this study?

You will be involved in the study for a maximum of 60 weeks (about 14 months), with treatment lasting up to 52 weeks.

Will I know if I'm getting the active medicine or the placebo?

In this type of study, participants usually don't know whether they are receiving the active medicine or the placebo. This helps prevent bias in the results.