Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
A legfontosabb adatok
- Ki végzi
- Pfizer
- Hol
- 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 és Waterford (Egyesült Államok)Mind a 28 helyszín megnézéseMég 5 másik országban, 42 helyszínen
- Azonosító
- Állapot
- Fut, nem toboroz
- Résztvevők
- 450 fő, tervezett
- Kezdés
- 2024. aug. 7.
- Várható befejezés
- 2028. ápr. 15.
- A vizsgálat típusa
- Megfigyeléses
- A vizsgált kezelések
- Ritlecitinib
- A regiszteradat frissítve
- 2026. november 6.
Ki vehet részt
- Életkor
- 12 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Helyszínek itt: Egyesült Államok
Még 5 másik országban, 42 helyszínen
- Oakland Hills DermatologyAuburn Hills, Egyesült ÁllamokNo longer taking part
- University of Alabama at BirminghamBirmingham, Egyesült ÁllamokNo longer taking part
- Dermatology of BocaBoca Raton, Egyesült ÁllamokNo longer taking part
- Brigham & Women's Hospital/Harvard Medical SchoolBoston, Egyesült ÁllamokNo longer taking part
- Raven Clinical ReseachBurlington, Egyesült ÁllamokNo longer taking part
- Pediatric Skin Research LLCCoral Gables, Egyesült ÁllamokNo longer taking part
- Raven Clinical ReseachFairfax, Egyesült ÁllamokNo longer taking part
- Center For Dermatology Clinical Research, Inc.Fremont, Egyesült ÁllamokNo longer taking part
- Rao DermatologyFresno, Egyesült ÁllamokNo longer taking part
- Goodlettsville Dermatology ResearchGoodlettsville, Egyesült ÁllamokNo longer taking part
- Hickory Dermatology Research CenterHickory, Egyesült ÁllamokNo longer taking part
- University of Iowa Health CareIowa City, Egyesült ÁllamokNo longer taking part
- Suncoast Skin SolutionsJacksonville, Egyesült ÁllamokNo longer taking part
- Kindred Hair and Skin CenterMarriottsville, Egyesült ÁllamokNo longer taking part
- Raven Clinical ReseachMcLean, Egyesült ÁllamokNo longer taking part
- Skin Research of South Florida, LlcMiami, Egyesült ÁllamokNo longer taking part
- University of MiamiMiami, Egyesült ÁllamokNo longer taking part
- Frontier DermatologyMill Creek, Egyesült ÁllamokNo longer taking part
- Twin Cities Dermatology CenterMinneapolis, Egyesült ÁllamokNo longer taking part
- University of MinnesotaMinneapolis, Egyesült ÁllamokNo longer taking part
- C2 Research CenterMontgomery, Egyesült ÁllamokNo longer taking part
- Cura Clinical ResearchOxnard, Egyesült ÁllamokNo longer taking part
- UPMCPittsburgh, Egyesült ÁllamokNo longer taking part
- NW Dermatology InstitutePortland, Egyesült ÁllamokNo longer taking part
- StanfordRedwood City, Egyesült ÁllamokNo longer taking part
- Southern California Clinical ResearchSanta Ana, Egyesült ÁllamokNo longer taking part
- Epiphany DermatologySouthlake, Egyesült ÁllamokNo longer taking part
- Michigan Dermatology InstituteWaterford, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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:
A teljes eredeti leírásKevesebb
* 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.
A vizsgálat csoportja
- Alopecia Areata (AA) patients treated with ritlecitinib
Kezelés: Ritlecitinib
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- PRESTO - CHARACTERIZATION AND CLINICAL OUTCOMES OF ALOPECIA AREATA (AA) PATIENTS TREATED WITH RITLECITINIB IN A REAL-WORLD (RW) COHORT: A MULTINATIONAL, PROSPECTIVE OBSERVATIONAL STUDY.
- A regiszteradat frissítve
- 2026. november 6.