Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Key facts
- Who runs it
- Pfizer
- Where
- Auburn Hills, Birmingham, Boca Raton, Boston, Burlington, Coral Gables, Fairfax, Fremont, Fresno, Goodlettsville, Hickory, Iowa City, Jacksonville, Marriottsville, McLean, Miami, Mill Creek, Minneapolis, Montgomery, Oxnard, Pittsburgh, Portland, Redwood City, Santa Ana, Southlake, and Waterford, United StatesSee the 28 sitesAlso in 5 other countries, 42 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 450 people, planned
- Started
- 7 Aug 2024
- Expected to end
- 15 Apr 2028
- Type of study
- Observational
- Treatments tested
- Ritlecitinib
- Record updated
- 6 November 2026
Who can take part
- Age
- 12 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Male and female patients aged >12 years at baseline
- 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
- 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
- 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
Who cannot take part
- Patients previously treated with ritlecitinib or other JAK inhibitors
- Diagnosed with other types of alopecia or other diseases that can cause hair loss (including, but not limited to known androgenetic alopecia, traction and scarring alopecia, telogen effluvium)
- 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
- 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
Where in United States
Also in 5 other countries, 42 sites
- Oakland Hills DermatologyAuburn Hills, United StatesNo longer taking part
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Dermatology of BocaBoca Raton, United StatesNo longer taking part
- Brigham & Women's Hospital/Harvard Medical SchoolBoston, United StatesNo longer taking part
- Raven Clinical ReseachBurlington, United StatesNo longer taking part
- Pediatric Skin Research LLCCoral Gables, United StatesNo longer taking part
- Raven Clinical ReseachFairfax, United StatesNo longer taking part
- Center For Dermatology Clinical Research, Inc.Fremont, United StatesNo longer taking part
- Rao DermatologyFresno, United StatesNo longer taking part
- Goodlettsville Dermatology ResearchGoodlettsville, United StatesNo longer taking part
- Hickory Dermatology Research CenterHickory, United StatesNo longer taking part
- University of Iowa Health CareIowa City, United StatesNo longer taking part
- Suncoast Skin SolutionsJacksonville, United StatesNo longer taking part
- Kindred Hair and Skin CenterMarriottsville, United StatesNo longer taking part
- Raven Clinical ReseachMcLean, United StatesNo longer taking part
- Skin Research of South Florida, LlcMiami, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Frontier DermatologyMill Creek, United StatesNo longer taking part
- Twin Cities Dermatology CenterMinneapolis, United StatesNo longer taking part
- University of MinnesotaMinneapolis, United StatesNo longer taking part
- C2 Research CenterMontgomery, United StatesNo longer taking part
- Cura Clinical ResearchOxnard, United StatesNo longer taking part
- UPMCPittsburgh, United StatesNo longer taking part
- NW Dermatology InstitutePortland, United StatesNo longer taking part
- StanfordRedwood City, United StatesNo longer taking part
- Southern California Clinical ResearchSanta Ana, United StatesNo longer taking part
- Epiphany DermatologySouthlake, United StatesNo longer taking part
- Michigan Dermatology InstituteWaterford, United StatesNo longer taking part
About the trial
What the trial wants to find out
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:
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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.
The group in the trial
- Alopecia Areata (AA) patients treated with ritlecitinib
Treatment: Ritlecitinib
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PRESTO - CHARACTERIZATION AND CLINICAL OUTCOMES OF ALOPECIA AREATA (AA) PATIENTS TREATED WITH RITLECITINIB IN A REAL-WORLD (RW) COHORT: A MULTINATIONAL, PROSPECTIVE OBSERVATIONAL STUDY.
- Record updated
- 6 November 2026