Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

B7981040 - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

This important study is looking into a new medicine called Ritlecitinib for people with vitiligo, which is a condition that causes patches of skin to lose their colour. The main goal is to find out if this medicine can help bring back skin colour and if it's safe to use over a year. Participants will be given either the new medicine, an existing treatment called Dexamethasone, or a dummy pill (placebo) without knowing which one. Researchers will regularly check how people's skin is changing and monitor for any side effects to make sure it's a good option for treating vitiligo.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Pfizer Inc.

Enrolment target

Start

04 Apr 2023

NON SEGMENTAL VITILIGO

What is this study about?

This study, called B7981040, is a major research project to understand a new medicine named Ritlecitinib for treating vitiligo. Vitiligo is a skin condition where patches of skin lose their natural colour. The medicine is being tested against Dexamethasone, which is a known treatment, and a dummy pill (placebo) to see how effective and safe it is. This type of study, a 'Phase 3' trial, is usually the last step before a medicine might be approved for wider use.

Over 52 weeks, or about a year, doctors will carefully watch how the skin changes in people taking part. They'll be looking to see if at least 75% of the lost skin colour in certain areas comes back. They will also keep a very close eye on any side effects, whether they are small or more serious, and if anyone needs to stop taking the medicine because of them. Blood tests will also be done to check for any unexpected changes in the body.

This research is really important because it could offer a new way to treat vitiligo, potentially helping many people improve their skin's appearance and how they feel about it. By comparing the new medicine to existing treatments and a placebo, the researchers can get a clear picture of its overall benefits and risks.

Key takeaways

Tests a new medicine (Ritlecitinib) for vitiligo.
Compares it to an existing treatment (Dexamethasone) and a dummy pill.
Aims to see if it brings back skin colour and is safe.
The study lasts for one year.
You won't know which treatment you're getting.
Open to adults aged 18 and over with non-segmental vitiligo.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

You must have a specific type of vitiligo called non-segmental vitiligo, which means the areas of lost skin colour show up on both sides of your body, rather than just one side or in specific patterns.

There will also be other health checks and requirements to make sure the study is right for you and safe. Your doctor will discuss all these with you in detail.

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 18 years old or older?
Do you have non-segmental vitiligo?
Are you able to attend regular clinic visits for one year?
Are you happy not knowing if you are getting the active medicine or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for about 52 weeks, which is a year. Throughout this time, you'll have regular visits to the clinic. At these visits, doctors will examine your skin, especially the areas affected by vitiligo. You'll also have blood tests and other checks to monitor your health and see how you're responding to the treatment.

You'll be given either the new medicine (Ritlecitinib), an existing medicine (Dexamethasone), or a dummy pill (placebo). You won't know which one you're taking, and neither will the doctors – this helps make the results fairer. You'll need to take the medicine as directed, usually every day. After the main treatment period, there might be a follow-up period to see how you're doing.

Potential risks and benefits

Taking part in this study could potentially help improve your vitiligo, as the new medicine might help bring back lost skin colour. However, it's also possible you might receive the placebo (dummy pill) or that the treatment won't work for you. As with any medicine, there's always a risk of side effects, ranging from mild to more serious. All known risks will be fully explained before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Bulgaria
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Unverified
Spain
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Unverified
Germany
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Unverified
Italy
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Unverified
Poland

Common questions

What is vitiligo?

Vitiligo is a skin condition where patches of your skin lose their colour, appearing lighter than your normal skin tone.

What is a 'Phase 3' study?

A 'Phase 3' study is a large-scale trial that checks if a new medicine is better than existing treatments or a dummy pill, and if it's safe, before it can be approved for general use.

Will I know if I'm getting the real medicine or a dummy pill?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're receiving the new medicine, the existing treatment, or the dummy pill (placebo). This helps make the study results fair.

How long will I be in the study?

The study runs for 52 weeks, which is about one year, with regular check-ups during that time.

What kind of vitiligo is being studied?

This study is specifically for 'non-segmental vitiligo', where the patches of lost colour appear on both sides of your body.