Actively Recruiting

Phase 3
Age: 6Years - 11Years
All Genders
NCT07029711

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

Led by Pfizer · Updated on 2026-03-30

225

Participants Needed

80

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss. This study is seeking participants who have: * at least 50% scalp hair loss due to alopecia areata. * received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports. * history of clinical response failure to alopecia areata treatment (for children in EU/UK only). All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo. The study medicine is a capsule that is taken by mouth. It is taken once each day at home. The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective. Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with alopecia areata (including alopecia totalis or universalis) with at least 50% scalp hair loss at screening and baseline without hair regrowth in the past 12 months
  • For EU/UK participants: history of treatment failure for alopecia areata
  • Documented evidence of two doses of varicella vaccination or prior exposure to varicella zoster virus by blood test
Not Eligible

You will not qualify if you...

  • Having other types of alopecia not related to alopecia areata, including congenital causes
  • Pre-existing hearing loss
  • Current or history of cancers or lymphoproliferative disorders such as lymphoma or leukemia
  • Clinically significant depression with a PROMIS T-score of 70 or higher
  • Untreated or poorly treated active or latent tuberculosis infection
  • History of severe or serious infections including cytomegalovirus, herpes zoster, disseminated herpes simplex, hepatitis B or C
  • Receipt of live attenuated vaccine within 6 weeks before starting study treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 80 locations

1

California Dermatology & Clinical Research Institute

Encinitas, California, United States, 92024

Actively Recruiting

2

University of California - Irvine

Irvine, California, United States, 92617

Actively Recruiting

3

Investigational Drug Service - Rady Children's Hospital-San Diego

San Diego, California, United States, 92123

Actively Recruiting

4

University of California, San Diego/Rady Children's Hospital-San Diego;

San Diego, California, United States, 92123

Actively Recruiting

5

Southern California Clinical Research

Santa Ana, California, United States, 92701

Actively Recruiting

6

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

7

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

8

Pediatric Skin Research

Miami, Florida, United States, 33156

Actively Recruiting

9

D&H Tamarac Research Center

Tamarac, Florida, United States, 33321

Actively Recruiting

10

Endeavor Health Clinical Operations

Skokie, Illinois, United States, 60077

Actively Recruiting

11

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States, 46250

Actively Recruiting

12

Equity Medical - Bowling Green

Bowling Green, Kentucky, United States, 42104

Actively Recruiting

13

Kindred Hair and Skin Center

Marriottsville, Maryland, United States, 21104

Actively Recruiting

14

Michigan Dermatology Institute

Waterford, Michigan, United States, 48328

Actively Recruiting

15

University of Minnesota Health Clinical Research Unit (M Health CRU)

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

16

Ear, Nose and Throat Consultants, LLC

Omaha, Nebraska, United States, 68144

Actively Recruiting

17

Skin Specialists, PC dba Schlessinger MD

Omaha, Nebraska, United States, 68144

Actively Recruiting

18

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

Papillion, Nebraska, United States, 68046

Actively Recruiting

19

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States, 87102

Actively Recruiting

20

University of New Mexico-IDS Pharmacy

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

21

Regents of the University of New Mexico

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

22

Equity Medical

New York, New York, United States, 10455

Actively Recruiting

23

Northwest Dermatology Institute

Portland, Oregon, United States, 97210

Actively Recruiting

24

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

25

Medical University of South Carolina Department of Dermatology and Dermatologic Surgery

Charleston, South Carolina, United States, 29425

Actively Recruiting

26

Driscoll Children's Hospital

Corpus Christi, Texas, United States, 78411

Actively Recruiting

27

3A Research - West Location

El Paso, Texas, United States, 79902

Active, Not Recruiting

28

Austin Institute for Clinical Research

Pflugerville, Texas, United States, 78660

Actively Recruiting

29

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

Actively Recruiting

30

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta, Canada, T5J 3S9

Actively Recruiting

31

CaRe Clinic

Red Deer, Alberta, Canada, T4P 1K4

Actively Recruiting

32

Medicine Professional Corporation

Peterborough, Ontario, Canada, K9J 5K2

Actively Recruiting

33

Research Toronto

Toronto, Ontario, Canada, M4W 2N4

Actively Recruiting

34

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

35

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100045

Actively Recruiting

36

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

37

The Second Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400010

Actively Recruiting

38

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510140

Actively Recruiting

39

Hunan Children's Hospital

Changsha, Hunan, China, 410007

Actively Recruiting

40

Xiangya Hospital Central South University

Changsha, Hunan, China, 410008

Not Yet Recruiting

41

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200040

Actively Recruiting

42

Chengdu Women and Children Center Hospital

Chengdu, Sichuan, China, 610091

Actively Recruiting

43

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China, 650032

Actively Recruiting

44

Kunming Children's hospital

Kunming, Yunnan, China, 650103

Not Yet Recruiting

45

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

46

Hangzhou Third Hospital

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

47

Shanghai Children's Hospital

Shanghai, China, 200062

Actively Recruiting

48

Fakultni Nemocnice Plzen

Pilsen, Czechia, 305 99

Actively Recruiting

49

Prof. MUDr. Petr Arenberger, DrSc., MBA

Prague, Czechia, 11000

Actively Recruiting

50

Fakultni nemocnice Bulovka

Prague, Czechia, 180 81

Not Yet Recruiting

51

Hospices Civils de Lyon - CIC - Hopital Louis Pradel

Bron, France, 69500

Actively Recruiting

52

Centre Hospitalier de Dijon Bourgogne - Hôpital François Mitterrand

Dijon, France, 21000

Not Yet Recruiting

53

GHICL - Service d'investigation - Recherche clinique

Lille, France, 59000

Not Yet Recruiting

54

GHICL - Hôpital Saint Vincent de Paul

Lille, France, 59020

Not Yet Recruiting

55

Centre Hospitalier Universitaire de Nice - Hopital l'Archet 2

Nice, France, 06200

Not Yet Recruiting

56

Hopital Enfants Malades Necker

Paris, France, 75015

Not Yet Recruiting

57

Hôpitaux Drôme Nord - Romans

Romans-sur-Isère, France, 26100

Not Yet Recruiting

58

Asst Spedali Civili Di Brescia

Brescia, Italy, 25123

Not Yet Recruiting

59

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Actively Recruiting

60

Niigata University Medical & Dental Hospital

Niigata, Niigata, Japan, 951-8520

Actively Recruiting

61

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan, 431-3192

Actively Recruiting

62

Kyorin University Hospital

Mitaka, Tokyo, Japan, 181-8611

Actively Recruiting

63

Osaka Metropolitan University Hospital

Osaka, Japan, 545-8586

Actively Recruiting

64

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski s.c.

Krakow, Lesser Poland Voivodeship, Poland, 30-002

Actively Recruiting

65

Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

Wroclaw, Lower Silesian Voivodeship, Poland, 50-566

Actively Recruiting

66

DERMEDIC Iwona Zdybska

Lublin, Lublin Voivodeship, Poland, 20-607

Actively Recruiting

67

Klinika Osipowicz & Turkowski

Warsaw, Masovian Voivodeship, Poland, 00-716

Actively Recruiting

68

Państwowy Instytut Medyczny MSWiA

Warsaw, Masovian Voivodeship, Poland, 02-507

Actively Recruiting

69

Provita Poliklinika

Warsaw, Masovian Voivodeship, Poland, 02-647

Actively Recruiting

70

Klinika Ambroziak Dermatologia

Warsaw, Masovian Voivodeship, Poland, 02-953

Actively Recruiting

71

Royalderm Agnieszka Nawrocka

Warsaw, Masovian Voivodeship, Poland, 02-962

Actively Recruiting

72

Nzoz Specjalistyczny Ośrodek Dermatologiczny "Dermal"

Bialystok, Podlaskie Voivodeship, Poland, 15-453

Actively Recruiting

73

Centrum Medyczne Angelius Provita

Katowice, Silesian Voivodeship, Poland, 40-611

Actively Recruiting

74

Labderm Essence Sp. Z o.o.

Ossy, Silesian Voivodeship, Poland, 42-624

Not Yet Recruiting

75

Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie

Rzeszów, Poland, 35-055

Not Yet Recruiting

76

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

Lodz, Łódź Voivodeship, Poland, 90-436

Actively Recruiting

77

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Actively Recruiting

78

Royal Alexandra Children's Hospital

Brighton, EAST Sussex, United Kingdom, BN2 5BE

Actively Recruiting

79

Guy's and St Thomas' NHS Foundation Trust

London, Greater London, United Kingdom, SE1 7EH

Actively Recruiting

80

Chelsea and Westminster Hospital NHS Foundation Trust

London, Greater London, United Kingdom, SW10 9NH

Actively 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

3

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