Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Start Date
8/7/2024
Completion Date
4/15/2028
Summary
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.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
Ritlecitinib
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
C2 Research Center
Montgomery, Alabama 36117
United States
CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc
Fremont, California 94538
United States
Rao Dermatology
Fresno, California 93720
United States
Rao Dermatology
Fresno, California 93720
United States
Cura Clinical Research
Oxnard, California 93030
United States
Stanford
Redwood City, California 94063
United States
Southern California Clinical Research
Santa Ana, California 92701
United States
Dermatology of Boca
Boca Raton, Florida 33431
United States
Pediatric Skin Research,LLC
Coral Gables, Florida 33146
United States
Suncoast Skin Solutions
Jacksonville, Florida 32256
United States
University of Miami
Miami, Florida 33136
United States
Skin Research of South Florida LLC
Miami, Florida 33173
United States
Kindred Hair and Skin Center
Marriottsville, Maryland 21104
United States
Brigham & Women's Hospital/Harvard Medical School
Boston, Massachusetts 02115
United States
Oakland Hills Dermatology
Auburn Hills, Michigan 48326
United States
Michigan Dermatology Institute
Waterford, Michigan 48328
United States
Twin Cities Dermatology Center
Minneapolis, Minnesota 55416
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Hickory Dermatology Research Center
Hickory, North Carolina 28602
United States
NW Dermatology Institute
Portland, Oregon 97210
United States
UPMC
Pittsburgh, Pennsylvania 15213
United States
Goodlettsville Dermatology Research
Goodlettsville, Tennessee 37072
United States
Epiphany Dermatology
Southlake, Texas 76092
United States
Raven Clinical Reseach
Fairfax, Virginia 22033
United States
Raven Clinical Reseach
McLean, Virginia 22102
United States
Frontier Dermatology
Mill Creek, Washington 98012
United States
Raven Clinical Reseach
Burlington, Wisconsin 53105
United States
Beijing Tongren Hospital
Beijing, 100006
China
Peking University First Hospital
Beijing, 100034
China
Peking University People's Hospital
Beijing, 100044
China
The Fist Hospital of Jilin Province
Changchun, 130021
China
The Fist Hospital of Jilin Province
Changchun, 130021
China
Xiangya Hospital, Central South University
Changsha, 410028
China
Dermatology Hospital of Southern Medical University
Guangzhou, 510091
China
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
China
Huashan Hospital Affiliated to Fudan University
Shanghai, 200040
China
Shanghai Skin Disease Hospital
Shanghai, 200443
China
University hospital of Bordeaux
Bordeaux, New Aquitaine 33000
France
Ch Victor Dupouy
Argenteuil, 95100
France
CHU de CAEN
Caen, 14033
France
Chu Dijon Bourgogne
Dijon, 21000
France
Chu Dijon Bourgogne
Dijon, 21000
France
CHU de Grenoble Alpes
La Tronche, 38700
France
CHU de Grenoble Alpes
La Tronche, 38700
France
Hôpital Saint Vincent de Paul
Lille, 59000
France
CHU de Rennes Hôpital Pontchaillou
Rennes, 35000
France
CHU de Rennes Hôpital Pontchaillou
Rennes, 35000
France
Rouen University Hospital
Rouen, 76000
France
Hôpital Larrey
Toulouse, 31059
France
Centre Sabouraud
Paris, Île-de-France Region 75010
France
Centre Sabouraud
Paris, Île-de-France Region 75010
France
A.O.U.C Policlinico de Bari
Bari, BA 70124
Italy
Istituto clinico Humanitas
Rozzano, Milan 20089
Italy
Irccs, Aoubo, Policlinico S.Orsola
Bologna, 40138
Italy
AO G. Rodolico - San Marco di Catania UOC DERMATOLOGIA
Catania, 95123
Italy
Policlinico Umberto I
Roma, 00161
Italy
Policlinico Tor Vergata
Rome, 00133
Italy
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka 807-8556
Japan
Kurume University Hospital
Kurume-shi, Fukuoka 830-0011
Japan
Nagomi Dermatology Clinic
Ebina, Kanagawa 243-0432
Japan
Tohoku University Hospital
Sendai, Miyagi 908-8574
Japan
Tohoku University Hospital
Sendai, Miyagi 908-8574
Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata 951-8520
Japan
Osaka Metropolitan University Hospital
Osaka, Osaka 545-0051
Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka 431-3192
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
Teikyo University Hospital
Itabashi-Ku, Tokyo 173-8606
Japan
Teikyo University Hospital
Itabashi-Ku, Tokyo 173-8606
Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo 160-0023
Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo 160-0023
Japan
University Hospitals Sussex
Brighton, EAST Sussex BN2 3EW
United Kingdom
University Hospitals Sussex
Brighton, EAST Sussex BN2 3EW
United Kingdom
NHS Fife
Dunfermline, FIFE KY120SU
United Kingdom
NHS Fife
Dunfermline, FIFE KY120SU
United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire GL13PX
United Kingdom
Royal United Hospital Bath
Bath, BA1 3NG
United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G4 0SF
United Kingdom
Whipps Cross (Barts Health)
London, E11 1NR
United Kingdom
London North West University Healthcare Trust
London, NW10 7NS
United Kingdom
Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH
United Kingdom