Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

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.

Overview

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.

Interventions

• Drug Ritlecitinib
  As provided in the real world practice.

Primary outcome measures

• Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24 [Time frame: 24 weeks from initiation of the treatment]

Secondary outcome measures (12)

• Demographic characteristic of participants: Age, sex, race, ethnicity, socio-economic status, area of residence, smoking status [Time frame: Baseline]
• Demographic Characteristic of Participants: Date of Initial AA diagnosis [Time frame: Baseline]
• Demographic Characteristics of participants: Duration of AA since diagnosis [Time frame: Baseline]
• Demographic characteristics of participants: Duration of current AA Episode [Time frame: Baseline]
• Demographic Characteristic of Participants: Predominant AA phenotype [Time frame: Baseline]
• Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score [Time frame: Baseline]
• Clinical characteristics of participants: Eyelash Assessment (ELA) score [Time frame: Baseline]
• Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score [Time frame: Baseline]
• Clinical Characteristics of participants: number of affected nails [Time frame: Baseline]
• Clinical Characteristics of participants: Presence of Beard involvement [Time frame: Baseline]
• AA treatment history of participants: number of patients with prior AA treatments [Time frame: Baseline]
• AA treatment history of participants: prior AA treatment class and route [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Patients previously treated with ritlecitinib or other JAK inhibitors.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 28 centers

• University of Alabama at Birmingham — Birmingham
• C2 Research Center — Montgomery
• CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc — Fremont
• Rao Dermatology — Fresno
• Rao Dermatology — Fresno
• Cura Clinical Research — Oxnard
• Stanford — Redwood City
• Southern California Clinical Research — Santa Ana
• … and 20 more centers

France · 14 centers

• University hospital of Bordeaux — Bordeaux
• Ch Victor Dupouy — Argenteuil
• CHU de CAEN — Caen
• Chu Dijon Bourgogne — Dijon
• Chu Dijon Bourgogne — Dijon
• CHU de Grenoble Alpes — La Tronche
• CHU de Grenoble Alpes — La Tronche
• Hôpital Saint Vincent de Paul — Lille
• … and 6 more centers

Japan · 13 centers

• Hospital of the University of Occupational and Environmental Health — Kitakyushu-shi
• Kurume University Hospital — Kurume-shi
• Nagomi Dermatology Clinic — Ebina
• Tohoku University Hospital — Sendai
• Tohoku University Hospital — Sendai
• Niigata University Medical & Dental Hospital — Niigata
• Osaka Metropolitan University Hospital — Osaka
• Hamamatsu University Hospital — Hamamatsu
• … and 5 more centers

China · 10 centers

• Beijing Tongren Hospital — Beijing
• Peking University First Hospital — Beijing
• Peking University People's Hospital — Beijing
• The Fist Hospital of Jilin Province — Changchun
• The Fist Hospital of Jilin Province — Changchun
• Xiangya Hospital, Central South University — Changsha
• Dermatology Hospital of Southern Medical University — Guangzhou
• Huashan Hospital Affiliated to Fudan University — Shanghai
• … and 2 more centers

United Kingdom · 10 centers

• University Hospitals Sussex — Brighton
• University Hospitals Sussex — Brighton
• NHS Fife — Dunfermline
• NHS Fife — Dunfermline
• Gloucestershire Hospitals NHS Foundation Trust — Gloucester
• Royal United Hospital Bath — Bath
• NHS Greater Glasgow and Clyde — Glasgow
• Whipps Cross (Barts Health) — London
• … and 2 more centers

Italy · 6 centers

• A.O.U.C Policlinico de Bari — Bari
• Istituto clinico Humanitas — Rozzano
• Irccs, Aoubo, Policlinico S.Orsola — Bologna
• AO G. Rodolico - San Marco di Catania UOC DERMATOLOGIA — Catania
• Policlinico Umberto I — Roma
• Policlinico Tor Vergata — Rome

Identifiers

NCT: NCT06531109 · B7981105 · NCT06531109

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗