Clinical Research Directory
Browse clinical research sites, groups, and studies.
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Sponsor: Pfizer
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.
Official title: PRESTO - Characterization and Clinical Outcomes of Alopecia Aerata (AA) Patients Treated With Ritlecitinib in a Real-world (RW) Cohort: A Multinational, Prospective Observational Study.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
850
Start Date
2024-08-07
Completion Date
2028-03-31
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
Ritlecitinib
As provided in the real world practice.
Locations (58)
C2 Research Center
Montgomery, Alabama, United States
CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc
Fremont, California, United States
Rao Dermatology
Fresno, California, United States
Cura Clinical Research
Oxnard, California, United States
Stanford
Redwood City, California, United States
Southern California Clinical Research
Santa Ana, California, United States
Dermatology of Boca
Boca Raton, Florida, United States
Pediatric Skin Research,LLC
Coral Gables, Florida, United States
Suncoast Skin Solutions
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Skin Research of South Florida LLC
Miami, Florida, United States
Kindred Hair and Skin Center
Marriottsville, Maryland, United States
Brigham & Women's Hospital/Harvard Medical School
Boston, Massachusetts, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Michigan Dermatology Institute
Waterford, Michigan, United States
Twin Cities Dermatology Center
Minneapolis, Minnesota, United States
Hickory Dermatology Research Center
Hickory, North Carolina, United States
NW Dermatology Institute
Portland, Oregon, United States
UPMC
Pittsburgh, Pennsylvania, United States
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
Epiphany Dermatology
Southlake, Texas, United States
Raven Clinical Reseach
Fairfax, Virginia, United States
Raven Clinical Reseach
McLean, Virginia, United States
Frontier Dermatology
Mill Creek, Washington, United States
Raven Clinical Reseach
Burlington, Wisconsin, United States
Beijing Tongren Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
The Fist Hospital of Jilin Province
Changchun, China
Xiangya Hospital, Central South University
Changsha, China
Dermatology Hospital of Southern Medical University
Guangzhou, China
Huashan Hospital Affiliated to Fudan University
Shanghai, China
Shanghai Skin Disease Hospital
Shanghai, China
Ch Victor Dupouy
Argenteuil, France
CHU de CAEN
Caen, France
Chu Dijon Bourgogne
Dijon, France
CHU de Grenoble Alpes
La Tronche, France
CHU de Rennes Hôpital Pontchaillou
Rennes, France
Rouen University Hospital
Rouen, France
Centre Sabouraud
Paris, Île-de-France Region, France
Hospital of the University of Occupational and Environmental Health
Kitakyushu-shi, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Nagomi Dermatology Clinic
Ebina, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Teikyo University Hospital
Itabashi-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
University Hospitals Sussex
Brighton, EAST SUSSEX, United Kingdom
NHS Fife
Dunfermline, FIFE, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, GLOUCESTERSHIRE, United Kingdom
Chelsea and Westminster NHS Foundation Trust
London, London, United Kingdom
Royal United Hospital Bath
Bath, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Whipps Cross (Barts Health)
London, United Kingdom
London North West University Healthcare Trust
London, United Kingdom