Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

B7981032 - A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA

This research is a phase 3 study, which means it's one of the final steps before a new medicine might become widely available. It's designed to understand how safe and effective a drug called Ritlecitinib is for people aged 18 and over who have alopecia areata. Alopecia areata causes hair loss, usually in patches. Participants will take the new medicine, and doctors will carefully check for any side effects and see how their hair growth changes over a long period. The main goal is to make sure the medicine is safe and to see if it helps reduce hair loss.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Pfizer Inc.

Enrolment target

162

Start

11 Jun 2024

Alopecia areata

What is this study about?

This study is focusing on a new medicine called Ritlecitinib for people who have alopecia areata. Alopecia areata is a condition where your immune system, which normally fights off germs, mistakenly attacks your hair follicles, leading to hair loss. This new medicine aims to calm down that immune reaction.

The main purpose of this study is to find out if Ritlecitinib is safe to use over a long time and how well it works to help people with alopecia areata. Researchers will be especially looking at any unwanted effects, also known as side effects, that people might experience while taking the medicine. They'll also be regularly checking participants' health, including vital signs like blood pressure and heart rate, and doing blood tests.

Another key part of the study is to see how much hair grows back. They will use a special scoring system to measure hair loss and regrowth. This study is important because it could lead to a new treatment option for people living with alopecia areata, helping to improve their hair health and overall well-being.

Key takeaways

This study evaluates a new medicine, Ritlecitinib, for alopecia areata.
It's a long-term study to check for safety and effectiveness.
Open to adults aged 18 and older with alopecia areata.
Participants will receive the active study medicine.
Regular health checks and hair growth measurements will be done.

Who may be eligible?

This study is open to adults aged 18 and older. Both men and women are welcome to take part in the research.

To be considered for this study, you must have alopecia areata. The study doctors will carefully check your medical history and conduct an examination to make sure the study is right for you.

There might be other specific health requirements or conditions that would prevent you from joining. These will be discussed in detail with the study team to ensure your safety and that the results of the study are clear.

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 a diagnosis of alopecia areata?
Are you able to attend regular clinic appointments for over three years?
Are you willing to take a new study medicine?
Are you comfortable with blood tests and physical examinations?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be taking the new medicine, Ritlecitinib. This is an "open-label" study, which means both you and the study doctors will know you are receiving the active medicine. The study involves regular visits to the clinic over a long period, potentially longer than three years.

During these visits, the study team will carry out various checks. This will include taking your vital signs (like temperature, blood pressure, and heart rate), taking blood samples for lab tests, and carefully asking about any health changes or side effects you might be experiencing. They will also measure your hair growth using a special tool to track how well the medicine is working. You will have a final check-up visit about 28 days after your last dose of the study medicine.

Potential risks and benefits

Participating in this trial could offer benefits, such as access to a new medicine for alopecia areata that isn't yet widely available. It might help improve your hair growth and overall condition. However, like all medicines, Ritlecitinib could have side effects, which might be mild or more serious. The study team will carefully monitor you for these. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual healthcare.

Locations (4)

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

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Unverified
Germany
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Unverified
Spain
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Unverified
Poland
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Unverified
Czechia

Common questions

What is alopecia areata?

Alopecia areata is a condition where your immune system mistakenly attacks your hair follicles, causing hair to fall out, often in patches.

What is Ritlecitinib?

Ritlecitinib is the name of the new medicine being tested in this study. It's designed to help calm the immune system reaction that causes hair loss in alopecia areata.

How long will the study last?

This is a long-term study, and participants will be followed for over three years to understand the medicine's effects over time.

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

Yes, this is an "open-label" study, meaning everyone involved, including you, will know you are receiving Ritlecitinib.

What kind of tests will I have during the study?

You'll have regular check-ups, including vital signs, blood tests, and measurements of your hair growth to see how the medicine is working.