NCT05583526

If you're considering treatment options, we invite you to learn more about the Tranquillo clinical trial

This study will help us learn if an oral investigational or study medicine is safe and if it could potentially treat vitiligo.

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Who may participate

When you participate in a study, you’re helping to represent yourself and other people with vitiligo across the globe. Your participation could help contribute to what we know about potential treatments. So, thank you for taking the time to learn more.


It’s important to remember that this is your journey and choice. You are free to stop being in this study at any time for any reason.

Condition

Nonsegmental vitiligo

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18+ years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

Get started — See if you may qualify

A first step as you consider this study is to answer a five-minute questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.

You will then be asked to provide your contact information for a study representative to contact you and discuss the next steps. If you’re interested, they will do a more detailed review of your medical history to see if you are able to participate. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.

Your answers to these initial questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you.

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What to expect

Before joining the trial, you will receive an Informed Consent Document (ICD) that you will go over with the study team. This is an important part of the clinical trial process that helps you better understand what it means to take part and what you can expect to happen during the study.

If you choose to sign the ICD, you will go through a screening period to make sure this study is right for you. This screening period may last up to 30 days and at this time the doctor will know if you can continue in the study. If you continue, the treatment period will be about one year long. During this time, you will be randomly assigned to receive daily oral capsules of either the study medicine or a placebo for about one year. You have a 33% (1 in 3) chance of receiving the placebo. A placebo does not contain any active ingredients, but the study medicine and the placebo look alike.

Length of study treatment

Approximately one year

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Approximately 11

Each clinical trial’s design specifies the number of study visits and the total length of the trial.

Follow-up

Four weeks

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This period allows us to monitor your health and safety.

Withdrawal extension study

Approximately one year

After the treatment period, participants who are eligible and choose to take part may roll over into a year-long withdrawal extension study.

An important contribution

An important contribution

Vitiligo is personal. When it comes to your skin, the best decision is your own. Wherever you are on your journey with vitiligo, we want to meet you where you are. By taking part in the Tranquillo clinical trial (or study), you could help advance research for people who have vitiligo. So, thank you for taking the time to learn more. 

Frequently asked questions

What is vitiligo?

For people with vitiligo, the relationship they have with their skin is a personal one. Because everyone’s journey with vitiligo is different, the best decision when it comes to their condition is their own.

As you may know, nonsegmental vitiligo is defined as an autoimmune condition. This means the immune system attacks healthy cells; in this case, pigment (or color)-producing cells called melanocytes.

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What is the investigational (or study) medicine and how does it work?

The investigational medicine, ritlecitinib, is [a janus kinase 3 (JAK3) inhibitor. It’s thought to work by blocking the signals and cells in the body that are believed to cause vitiligo.

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Will I receive the study drug?

Your study group will be chosen randomly (like flipping a coin) rather than by choice. This is called randomization, and it’s one way to help avoid bias in a research study. You have a 33% (1 in 3) chance of receiving the placebo. Since this study is double-blinded, neither you, your study doctor, nor the study team will know if you receive the study medicine or the placebo.

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How is the study drug taken?

The study medicine is a once-daily oral capsule that you’ll take for approximately one year. If possible, take it around the same time every day, with or without food. On study visit days, we ask that you take your dose at the site instead of at home.

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