Actively Recruiting

Age: 12Years +
All Genders
NCT06531109

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

Led by Pfizer · Updated on 2026-02-20

850

Participants Needed

58

Research Sites

190 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Alopecia areata (AA) is a chronic relapsing autoimmune disease characterized by nonscarring hair loss affecting children, adolescents, and adults across all ages, races, and genders. AA primarily affects the scalp; however, it also can affect nails, eyelashes, eyebrows, and other hair follicles on the patient's body. The 3 main types of AA are: * Patchy alopecia (PA), as seen in 90% of clinical diagnoses * Alopecia totalis (AT), that affects all scalp hair * Alopecia universalis (AU), involving all scalp, face, and body hair Dermatologist preferences for utility and order of skin-directed therapies to treat AA vary widely, with treatment choices based on various factors such as patients' age, disease duration and severity (Meah et al., 2020). Ritlecitinib is a bioavailable small molecule that irreversibly binds to Janus kinase-3 (JAK3) and Tyrosine kinase Expressed in the hepatocellular Carcinoma kinase family (TEC). Ritlecitinib 50 mg once daily was approved by the FDA 23 June 2023 and EMA 20 July 2023 for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. In Japan, ritlecitinib was approved on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Additional countries have since approved ritlecitinib. Those approvals are based on the results of the ritlecitinib pivotal phase 2b/3 study (ALLEGRO 2b/3) which examined efficacy and safety of ritlecitinib in AA patients globally. Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine clinical practice. The investigators will evaluate patient and disease characteristics, treatment patterns, and clinical and patient-reported outcomes among patients with AA who are receiving ritlecitinib. The aim of this study is to measure effectiveness of ritlecitinib in a real-world setting. Ritlecitinib will be prescribed to patients according to the approved product label. Treatment will be guided by clinical judgement of the treating physician ie, study investigators, according to standard of care, independently of this study.

CONDITIONS

Official Title

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged >12 years at baseline
  • Diagnosis of alopecia areata confirmed by a certified dermatologist
  • Prescribed ritlecitinib according to the product label independently of study enrollment
  • Signed informed consent document obtained from patient or legally acceptable representative
  • Adolescents must provide assent per local requirements, and parents or guardians must provide consent
  • Willing and able to comply with regular clinic visits and complete patient-reported outcome questionnaires
Not Eligible

You will not qualify if you...

  • Diagnosed with other types of alopecia or diseases causing hair loss (e.g., androgenetic alopecia, traction alopecia, telogen effluvium)
  • Diagnosed with scalp diseases affecting AA assessment (e.g., scalp psoriasis, dermatitis) or active systemic diseases causing hair loss (e.g., lupus erythematosus, thyroiditis)
  • Previously treated with ritlecitinib or other JAK inhibitors
  • Investigator site staff, Pfizer employees involved in the study, or their family members

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 58 locations

1

C2 Research Center

Montgomery, Alabama, United States, 36117

Actively Recruiting

2

CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc

Fremont, California, United States, 94538

Actively Recruiting

3

Rao Dermatology

Fresno, California, United States, 93720

Actively Recruiting

4

Cura Clinical Research

Oxnard, California, United States, 93030

Actively Recruiting

5

Stanford

Redwood City, California, United States, 94063

Not Yet Recruiting

6

Southern California Clinical Research

Santa Ana, California, United States, 92701

Actively Recruiting

7

Dermatology of Boca

Boca Raton, Florida, United States, 33431

Actively Recruiting

8

Pediatric Skin Research,LLC

Coral Gables, Florida, United States, 33146

Actively Recruiting

9

Suncoast Skin Solutions

Jacksonville, Florida, United States, 32256

Actively Recruiting

10

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

11

Skin Research of South Florida LLC

Miami, Florida, United States, 33173

Actively Recruiting

12

Kindred Hair and Skin Center

Marriottsville, Maryland, United States, 21104

Actively Recruiting

13

Brigham & Women's Hospital/Harvard Medical School

Boston, Massachusetts, United States, 02115

Actively Recruiting

14

Oakland Hills Dermatology

Auburn Hills, Michigan, United States, 48326

Actively Recruiting

15

Michigan Dermatology Institute

Waterford, Michigan, United States, 48328

Actively Recruiting

16

Twin Cities Dermatology Center

Minneapolis, Minnesota, United States, 55416

Active, Not Recruiting

17

Hickory Dermatology Research Center

Hickory, North Carolina, United States, 28602

Actively Recruiting

18

NW Dermatology Institute

Portland, Oregon, United States, 97210

Actively Recruiting

19

UPMC

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

20

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, United States, 37072

Actively Recruiting

21

Epiphany Dermatology

Southlake, Texas, United States, 76092

Actively Recruiting

22

Raven Clinical Reseach

Fairfax, Virginia, United States, 22033

Actively Recruiting

23

Raven Clinical Reseach

McLean, Virginia, United States, 22102

Actively Recruiting

24

Frontier Dermatology

Mill Creek, Washington, United States, 98012

Actively Recruiting

25

Raven Clinical Reseach

Burlington, Wisconsin, United States, 53105

Actively Recruiting

26

Beijing Tongren Hospital

Beijing, China, 100006

Actively Recruiting

27

Peking University First Hospital

Beijing, China, 100034

Actively Recruiting

28

Peking University People's Hospital

Beijing, China, 100044

Actively Recruiting

29

The Fist Hospital of Jilin Province

Changchun, China, 130021

Not Yet Recruiting

30

Xiangya Hospital, Central South University

Changsha, China, 410028

Actively Recruiting

31

Dermatology Hospital of Southern Medical University

Guangzhou, China, 510091

Actively Recruiting

32

Huashan Hospital Affiliated to Fudan University

Shanghai, China, 200040

Actively Recruiting

33

Shanghai Skin Disease Hospital

Shanghai, China, 200443

Actively Recruiting

34

Ch Victor Dupouy

Argenteuil, France, 95100

Not Yet Recruiting

35

CHU de CAEN

Caen, France, 14033

Actively Recruiting

36

Chu Dijon Bourgogne

Dijon, France, 21000

Not Yet Recruiting

37

CHU de Grenoble Alpes

La Tronche, France, 38700

Not Yet Recruiting

38

CHU de Rennes Hôpital Pontchaillou

Rennes, France, 35000

Not Yet Recruiting

39

Rouen University Hospital

Rouen, France, 76000

Actively Recruiting

40

Centre Sabouraud

Paris, Île-de-France Region, France, 75010

Not Yet Recruiting

41

Hospital of the University of Occupational and Environmental Health

Kitakyushu-shi, Fukuoka, Japan, 807-8556

Actively Recruiting

42

Kurume University Hospital

Kurume-shi, Fukuoka, Japan, 830-0011

Actively Recruiting

43

Nagomi Dermatology Clinic

Ebina, Kanagawa, Japan, 243-0432

Actively Recruiting

44

Tohoku University Hospital

Sendai, Miyagi, Japan, 908-8574

Not Yet Recruiting

45

Niigata University Medical & Dental Hospital

Niigata, Niigata, Japan, 951-8520

Actively Recruiting

46

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan, 545-0051

Actively Recruiting

47

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan, 431-3192

Actively Recruiting

48

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan, 113-8431

Actively Recruiting

49

Teikyo University Hospital

Itabashi-Ku, Tokyo, Japan, 173-8606

Not Yet Recruiting

50

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, Japan, 160-0023

Not Yet Recruiting

51

University Hospitals Sussex

Brighton, EAST SUSSEX, United Kingdom, BN2 3EW

Not Yet Recruiting

52

NHS Fife

Dunfermline, FIFE, United Kingdom, KY120SU

Not Yet Recruiting

53

Gloucestershire Hospitals NHS Foundation Trust

Gloucester, GLOUCESTERSHIRE, United Kingdom, GL13PX

Actively Recruiting

54

Chelsea and Westminster NHS Foundation Trust

London, London, United Kingdom, SW10 9NH

Actively Recruiting

55

Royal United Hospital Bath

Bath, United Kingdom, BA1 3NG

Actively Recruiting

56

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom, G4 0SF

Actively Recruiting

57

Whipps Cross (Barts Health)

London, United Kingdom, E11 1NR

Actively Recruiting

58

London North West University Healthcare Trust

London, United Kingdom, NW10 7NS

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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