RecruitingPHASE3INTERVENTIONAL

A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.

This study is for children with severe alopecia areata, a condition that causes significant hair loss. It's a long-term study to find out more about a medicine called ritlecitinib. The main goal is to see how safe the medicine is and how well it works over a longer period. Only children who have already taken part in one of Pfizer's earlier studies (B7981027 or B7981031) for alopecia areata can join this study. All participants will receive ritlecitinib, taken as a daily capsule. The study will last up to three years and involves regular visits to the clinic and phone calls to check on progress.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

140

Start

10 Sep 2025

Estimated completion

26 Jun 2030

Severe Alopecia Areata

What is this study about?

This research study is looking into a medicine called ritlecitinib for children and young people who have severe alopecia areata. Alopecia areata is a condition where the body's immune system mistakenly attacks hair follicles, leading to hair loss, sometimes all over the head or body. Severe means a lot of hair loss, in this case, affecting at least half of the scalp.

The main aim of this study is to understand the long-term effects of ritlecitinib. We want to see how safe it is to take over a longer period and how well it helps with hair regrowth. The study is a continuation for children who have already taken part in a previous Pfizer study (named B7981027 or B7981031) looking at the same medicine. This means we're building on what we've already learned.

All participants will receive the study medicine, ritlecitinib, which is taken as a capsule once a day. Some participants will receive a higher dose, and others a lower dose. We hope this study will give us important information about how ritlecitinib can help children manage their alopecia areata in the long run.

Key takeaways

This study is for children with severe alopecia areata who were in prior Pfizer studies.
It aims to understand the long-term safety and effects of ritlecitinib.
Participants take a daily capsule of ritlecitinib (either a higher or lower dose).
The study lasts up to 3 years and involves clinic visits and phone calls.
It helps researchers learn more about how to treat alopecia areata.
Your health and safety will be carefully monitored throughout the study.

Who may be eligible?

To be able to join this study, children must have previously taken part in one of Pfizer's earlier studies for alopecia areata (either B7981027 or B7981031). If they are joining from study B7981031, they need to have lost at least half of their scalp hair due to alopecia areata.

There are also some health requirements. Participants must have had the chickenpox vaccine (two doses) or have had chickenpox before, confirmed by a blood test. There are certain health conditions or past serious infections, including some types of cancer or long-term infections like TB or hepatitis, that would prevent someone from joining to ensure their safety.

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.

Have I previously taken part in Pfizer's study B7981027 or B7981031?
If I was in study B7981031, do I have at least 50% hair loss on my scalp?
Have I had two chickenpox vaccinations or had chickenpox before?
Do I have any current or past serious health issues like certain cancers or untreated infections (like TB or hepatitis)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will take the study medicine, ritlecitinib, once a day as a capsule. You will be in the study for up to three years (36 months). During this time, you will have 17 visits to the study clinic for check-ups and assessments. The study team will also call you once a month to see how you are doing. These visits and calls help the doctors monitor your health and see how well the medicine is working. If the medicine isn't helping as expected after a certain time, or if there are safety concerns, your participation in the study medicine part might stop.

Potential risks and benefits

Taking part in this study could offer the potential benefit of continuing treatment for your alopecia areata with ritlecitinib, which may help with hair regrowth. However, like all medicines, ritlecitinib can have side effects, and the study will carefully monitor for any potential risks. You will be told about all known risks before you decide to join. Remember, participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (41)

California Dermatology & Clinical Research Institute
Verified postcode
Encinitas, United States· Recruiting
Pediatric Skin Research
Verified postcode
Miami, United States· Recruiting
D&H Tamarac Research Center
Verified postcode
Tamarac, United States· Not yet recruiting
Dawes Fretzin Clinical Research Group, LLC
Verified postcode
Indianapolis, United States· Recruiting
Kindred Hair and Skin Center
Verified postcode
Marriottsville, United States· Not yet recruiting
Michigan Dermatology Institute
Verified postcode
Waterford, United States· Not yet recruiting
Ear, Nose & Throat Consultants, LLC
Verified postcode
Omaha, United States· Recruiting
Skin Specialists, PC dba Schlessinger MD
Verified postcode
Omaha, United States· Recruiting
Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)
Verified postcode
Papillion, United States· Recruiting
University of New Mexico Health Sciences Center
Verified postcode
Albuquerque, United States· Recruiting
University of New Mexico-IDS Pharmacy
Verified postcode
Albuquerque, United States· Recruiting
Regents of the University of New Mexico
Verified postcode
Albuquerque, United States· Recruiting

Common questions

What is ritlecitinib?

Ritlecitinib is the name of the medicine being tested in this study. It's a type of drug that aims to help with hair loss caused by severe alopecia areata.

Who can join this study?

Only children who have already taken part in Pfizer's previous alopecia areata studies (B7981027 or B7981031) can join this study.

How long will the study last?

The study will last for up to three years (36 months).

Will I have to take daily medicine?

Yes, all participants in this study will take the study medicine, ritlecitinib, as a capsule once a day.

What kind of visits will I have?

You will have regular visits to the study clinic (17 over three years) and monthly phone calls with the study team.

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.