Actively Recruiting

Phase 3
Age: 6Years - 14Years
All Genders
NCT07029828

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

Led by Pfizer · Updated on 2026-04-28

140

Participants Needed

41

Research Sites

250 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss. This study is seeking participants who have: * previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031). * at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031). * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial. Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial. The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home. The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with alopecia areata (including alopecia totalis and alopecia universalis) who completed studies B7981027 or B7981031
  • Participants from Study B7981031 must have at least 50% scalp hair loss (SALT score 6550) at Screening and Baseline visits
Not Eligible

You will not qualify if you...

  • Participants from Study B7981027 with 64 days between last dose and first visit of this study who had safety events requiring permanent discontinuation
  • Participants discontinued from Study B7981027 for reasons other than safety must have resolved those issues before enrolling
  • Participants from Study B7981031 or from Study B7981027 with more than 30 days between last dose and first visit who had safety events requiring permanent discontinuation
  • Any current or past malignancies or lymphoproliferative disorders
  • Untreated or inadequately treated active or latent tuberculosis infection
  • History of severe or serious cytomegalovirus, herpes zoster, or disseminated herpes simplex infections
  • Infection with hepatitis B or hepatitis C virus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 41 locations

1

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

Actively Recruiting

2

Pediatric Skin Research

Miami, Florida, United States, 33156

Actively Recruiting

3

D&H Tamarac Research Center

Tamarac, Florida, United States, 33321

Not Yet Recruiting

4

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Actively Recruiting

5

Kindred Hair and Skin Center

Marriottsville, Maryland, United States, 21104

Not Yet Recruiting

6

Michigan Dermatology Institute

Waterford, Michigan, United States, 48328

Not Yet Recruiting

7

Ear, Nose & Throat Consultants, LLC

Omaha, Nebraska, United States, 68144

Actively Recruiting

8

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, United States, 68144

Actively Recruiting

9

Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)

Papillion, Nebraska, United States, 68046

Actively Recruiting

10

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States, 87102

Actively Recruiting

11

University of New Mexico-IDS Pharmacy

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

12

Regents of the University of New Mexico

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

13

Equity Medical, LLC

The Bronx, New York, United States, 10455

Not Yet Recruiting

14

Northwest Dermatology Institute

Portland, Oregon, United States, 97210

Actively Recruiting

15

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Not Yet Recruiting

16

Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

Charleston, South Carolina, United States, 29425

Not Yet Recruiting

17

3A Research

El Paso, Texas, United States, 79902

Actively Recruiting

18

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

Actively Recruiting

19

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

20

Prof. MUDr. Petr Arenberger, DrSc., MBA

Prague, Czechia, 11000

Not Yet Recruiting

21

Hospices Civils de Lyon - Hopital Femme Mere Enfant

Bron, France, 69500

Not Yet Recruiting

22

CHU de Dijon Bourgogne

Dijon, France, 21079

Not Yet Recruiting

23

GHICL - Service d'investigation - Recherche clinique

Lille, France, 59000

Not Yet Recruiting

24

Hôpital Saint Vincent de Paul

Lille, France, 59020

Not Yet Recruiting

25

Centre Hospitalier Universitaire de Nice

Nice, France, 06202

Not Yet Recruiting

26

Hôpitaux Drôme Nord

Romans-sur-Isère, France, 26100

Not Yet Recruiting

27

Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey

Toulouse, France, 31400

Not Yet Recruiting

28

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Not Yet Recruiting

29

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan, 431-3192

Actively Recruiting

30

Kyorin University Hospital

Mitaka, Tokyo, Japan, 181-8611

Not Yet Recruiting

31

Osaka Metropolitan University Hospital

Osaka, Japan, 545-8586

Actively Recruiting

32

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, Poland, 50-566

Not Yet Recruiting

33

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, Poland, 20-607

Not Yet Recruiting

34

Klinika Osipowicz & Turkowski

Warsaw, Masovian Voivodeship, Poland, 00-716

Not Yet Recruiting

35

Państwowy Instytut Medyczny MSWiA

Warsaw, Masovian Voivodeship, Poland, 02-507

Not Yet Recruiting

36

Provita Poliklinika

Warsaw, Masovian Voivodeship, Poland, 02-647

Not Yet Recruiting

37

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, Poland, 02-953

Not Yet Recruiting

38

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, Poland, 02-962

Not Yet Recruiting

39

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland, 40-611

Not Yet Recruiting

40

Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie

Rzeszów, Poland, 35-055

Not Yet Recruiting

41

Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

Lodz, Łódź Voivodeship, Poland, 90-436

Not Yet Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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