RecruitingPHASE3INTERVENTIONAL

A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata

This study is exploring a new medicine called ritlecitinib for children aged 6 to 11 who have severe alopecia areata, a condition where people lose a lot of their hair. The main goal is to find out if this medicine is safe and effective in helping hair grow back. Some children will receive a higher dose of ritlecitinib, some a lower dose, and others a placebo – which looks like the medicine but contains no active drug. This helps researchers compare the effects. Participants will take the medicine daily as a capsule for 6 months and will have regular clinic visits and phone calls to check on their progress and well-being. It’s important to see if ritlecitinib can improve hair regrowth and daily life for children with this condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

225

Start

31 Jul 2025

Estimated completion

18 May 2027

Severe Alopecia Areata

What is this study about?

This research study is looking at a new medicine called ritlecitinib, which could potentially help children aged 6 to 11 who have severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss. In severe cases, people can lose a lot of hair from their scalp, and sometimes from other parts of the body. The purpose of this study is to carefully check if ritlecitinib is safe for children and if it can help their hair grow back.

To understand how well ritlecitinib works, participants will be put into three groups. One group will receive a higher dose of ritlecitinib, another group will get a lower dose, and the third group will receive a 'placebo'. A placebo looks exactly like the study medicine but doesn't contain any active drug. This comparison helps the researchers to clearly see if any improvements are due to the medicine itself or other factors. All participants will take the study medicine as a capsule by mouth once a day.

By comparing the experiences of children taking ritlecitinib with those taking the placebo, the study hopes to learn more about the potential benefits and any side effects of the medicine. This information is crucial for deciding if ritlecitinib could eventually become a treatment option for children with severe alopecia areata. The study also aims to understand how the medicine affects a child's overall well-being and daily life.

Key takeaways

Study for children aged 6-11 with severe alopecia areata.
Investigates a new medicine called ritlecitinib.
Compares ritlecitinib to a placebo (dummy medicine).
Participation involves taking a daily capsule for 6 months.
Includes 8 clinic visits and 8 phone check-ups.
Aims to assess safety and hair regrowth.

Who may be eligible?

This study is looking for children aged 6 to 11 years old. They need to have severe alopecia areata, meaning they've lost at least half of their scalp hair, and this hair loss hasn't improved in the last year. For children living in the UK or EU, they'll also need to have tried other alopecia areata treatments that didn't work well.

All children joining the study must have either had two chickenpox vaccinations or show signs in a blood test that they've had chickenpox before. This is because certain medications can interact with the chickenpox virus.

There are also some reasons why a child might not be able to join the study. For example, if they have certain other types of hair loss, serious medical conditions like some cancers, a history of significant depression, or untreated infections like tuberculosis or hepatitis. Also, if they've had a 'live' vaccine recently, they might need to wait before joining.

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.

Is your child between 6 and 11 years old?
Has your child lost at least half of their scalp hair due to alopecia areata and it hasn't regrown in the last year?
For UK/EU children: Have other alopecia treatments not worked for your child?
Has your child had two chickenpox jabs, or have they had chickenpox before (confirmed by a blood test)?
Does your child have any other serious medical conditions like certain severe infections or past cancers?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive a study medicine (ritlecitinib) or a placebo, which is a dummy medicine, in the form of a capsule to take by mouth once a day at home. This will continue for 6 months. During this time, you and your child will attend the study clinic for 8 appointments. These visits are important for the study team to check your child's health, see how the medicine is working, and look for any side effects. The study team will also call you about 8 times over the phone to check in and see how things are going. After the 6 months, if your child meets certain conditions, they might have the option to join a longer-term part of the study.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. Your child might benefit from better hair growth if the study medicine is effective. However, there's no guarantee it will work, and your child might receive a placebo. Possible risks include side effects from the medicine, though these will be closely monitored. The study team will explain all known risks. Your child's well-being is the top priority, and you are free to withdraw your child from the study at any time, for any reason, without it affecting their future medical care.

Locations (80)

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· Recruiting
University of California - Irvine
Verified postcode
Irvine, United States· Recruiting
Investigational Drug Service - Rady Children's Hospital-San Diego
Verified postcode
San Diego, United States· Recruiting
University of California, San Diego/Rady Children's Hospital-San Diego;
Verified postcode
San Diego, United States· Recruiting
Southern California Clinical Research
Verified postcode
Santa Ana, United States· Recruiting
Children's Hospital Colorado
Verified postcode
Aurora, United States· Recruiting
Children's National Medical Center
Verified postcode
Washington D.C., United States· Recruiting
Pediatric Skin Research
Verified postcode
Miami, United States· Recruiting
D&H Tamarac Research Center
Verified postcode
Tamarac, United States· Recruiting
Endeavor Health Clinical Operations
Verified postcode
Skokie, United States· Recruiting
Dawes Fretzin Clinical Research Group, LLC
Verified postcode
Indianapolis, United States· Recruiting
Equity Medical - Bowling Green
Verified postcode
Bowling Green, United States· Recruiting

Common questions

What is alopecia areata?

Alopecia areata is a condition where your immune system, which normally fights off infections, mistakenly attacks your hair follicles, leading to hair loss on the scalp and sometimes other parts of the body.

What is a 'placebo'?

A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare if the real medicine is having an effect.

How long does the study last?

The main part of the study will last for 6 months for your child. During this time, there will be 8 clinic visits and about 8 phone calls with the study team.

Will my child know if they are getting the real medicine or the placebo?

No, neither you, your child, nor the study team will know which treatment your child is receiving during the main 6-month period. This is to ensure the results are fair and unbiased.

What if my child feels unwell during the study?

Any concerns about your child's health must be reported immediately to the study team, who will provide guidance and care.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.