Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
NCT ID: NCT06531109
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
850 participants
OBSERVATIONAL
2024-08-07
2027-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Alopecia Areata (AA) patients treated with ritlecitinib
Ritlecitinib
As provided in the real world practice.
Interventions
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Ritlecitinib
As provided in the real world practice.
Eligibility Criteria
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Inclusion Criteria
2. Patients with diagnosis of alopecia areata confirmed by a certified dermatologist, who are prescribed ritlecitinib as per the product label independently of the decision to enroll a patient in this study.
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Following receipt of oral and written information about the trial, the adolescent (depending on local institutional review board/independent ethics committee requirements) must provide assent, and one or both (according to local regulations) parents or guardians of the child must provide signed informed consent before any study-related activity is carried out.
4. Patients, who in the opinion of the investigator, are willing and able to comply with regular clinic visits as per standard practice at the site and agree to complete PRO questionnaires and other patient completed questions.
Exclusion Criteria
2. Diagnosed with other scalp diseases that may impact AA assessment (e.g., scalp psoriasis, dermatitis, etc.) or other active systemic diseases that may cause hair loss (e.g., lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc.). that could interfere with assessment of hair loss/regrowth.
3. Patients previously treated with ritlecitinib or other JAK inhibitors.
4. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
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
Central Missouri Dermatology Research
Columbia, Missouri, 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
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
Rouen University Hospital
Rouen, , 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
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
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, 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
Chelsea and Westminster NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06531109
Identifier Type: REGISTRY
Identifier Source: secondary_id
B7981105
Identifier Type: -
Identifier Source: org_study_id
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