Active not recruitingPHASE3INTERVENTIONAL

A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

This study is investigating a medicine called ritlecitinib for treating alopecia areata, a condition causing hair loss. Ritlecitinib is already approved in some countries at a 50mg dose. This study will compare that dose with a higher 100mg dose to see if it's also safe and effective. Researchers want to find out if the 100mg dose helps hair grow back and if it has any side effects. Participants, aged 12 and older with significant scalp hair loss due to alopecia areata, will take part. They will be randomly assigned to receive one of the doses, or a dummy pill (placebo), and will be observed for about 13 months with regular check-ups.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

550

Start

01 Apr 2025

Estimated completion

21 Dec 2026

Alopecia Areata

What is this study about?

Alopecia areata is a common condition where the immune system mistakenly attacks hair follicles, leading to hair loss on the scalp, face, and sometimes other parts of the body. While there are some treatments available, researchers are always looking for new and effective options.

This particular study is focusing on a medicine called ritlecitinib. It's designed to help calm down the immune system's overreaction that causes hair loss. A 50mg dose of ritlecitinib is already used in many countries for severe alopecia areata in people aged 12 and above. Now, doctors want to see if a higher 100mg dose might be even more effective, while still being safe.

The main goal of this study is to compare the 50mg and 100mg doses of ritlecitinib. They want to check how well both doses work in helping hair grow back, as well as keeping a close eye on any potential side effects. By carefully studying these two doses, researchers hope to better understand the best way to use ritlecitinib to help people living with alopecia areata.

Key takeaways

This study evaluates two doses (50mg and 100mg) of ritlecitinib for alopecia areata.
Ritlecitinib aims to help hair regrowth by addressing the immune system.
Participants will be aged 12 and older with significant scalp hair loss.
The study lasts about 13 months with regular clinic visits.
You will be randomly assigned to receive ritlecitinib or a placebo.
Participation includes various health checks and questionnaires.

Who may be eligible?

To join this study, you need to be at least 12 years old and have a clear diagnosis of alopecia areata. This means your doctor has confirmed your hair loss is due to this specific condition, and not something else. You must also have lost at least half of the hair on your scalp.

It's important that your hair loss specifically due to alopecia areata and not another medical issue. Also, your current episode of hair loss shouldn't have started more than 10 years ago. You must be willing to stop any other alopecia areata treatments you're currently using while you're in the study.

There are also some reasons why you might not be able to join. For example, if you have other conditions that cause hair loss, a history of serious allergic reactions to similar medicines, or certain infections, you might not be eligible. The study team will discuss all these details with you thoroughly to make sure taking part is safe and suitable for you.

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 12 years of age or older?
Have you been diagnosed with alopecia areata?
Have you lost 50% or more of the hair on your scalp?
Is your current hair loss episode 10 years old or less?
Are you willing to stop any other alopecia areata treatments if you join?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be involved for about 13 months. During this time, you'll be asked to visit the study clinic up to 9 times. When you join, you'll be randomly assigned, like drawing names out of a hat, to receive one of the two doses of ritlecitinib (50mg or 100mg), or a dummy pill called a placebo. You'll take your assigned medicine by mouth once a day.

During your visits, the study team will carry out several checks. These will include assessing your hair loss, having physical examinations, hearing tests, and blood tests. You might also have an X-ray and an ECG (a test that checks your heart's electrical activity). They'll take photographs of your scalp and eyes to track any changes. You'll also be asked to fill in some questionnaires about your alopecia areata and how you're feeling.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to a new treatment before it's widely available and contributing to medical knowledge that could help others. However, there are also potential risks, as with any medication. You might experience side effects from the study medicine, or the treatment might not work for you. There will also be appointments and tests that take up your time. It's very important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (143)

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

The Kirklin Clinic of UAB Hospital (Radiology)
Verified postcode
Birmingham, United States
University of Alabama at Birmingham Faculty Office Towers (Regulatory)
Verified postcode
Birmingham, United States
University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Burke Pharmaceutical Research
Verified postcode
Hot Springs, United States
Doc1 Healthcare Systems
Verified postcode
Brea, United States
Doc1 Healthcare Systems
Verified postcode
Chino, United States
California Dermatology & Clinical Research Institute
Verified postcode
Encinitas, United States
Marvel Clinical Research
Verified postcode
Huntington Beach, United States
Southern California Clinical Research
Verified postcode
Santa Ana, United States
Brett King MD, LLC
Verified postcode
Fairfield, United States
Alliance for Multispecialty Research, LLC
Verified postcode
Fort Myers, United States
Robert B. Pritt, DO, PA
Verified postcode
Fort Myers, United States

Common questions

What is alopecia areata?

Alopecia areata is a condition where your immune system attacks your hair follicles, leading to patches of hair loss on your scalp, face, and sometimes other parts of your body.

What is ritlecitinib?

Ritlecitinib is a type of medicine designed to help calm the immune system's activity that causes hair loss in alopecia areata.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.

How long will I be in the study?

If you join, you'll be part of the study for about 13 months, with up to 9 visits to the clinic during that time.

Can I continue my other hair loss treatments?

No, if you join this study, you'll need to stop any other treatments you're currently taking for your alopecia areata.