Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
NCT Number: NCT06531109
Acronym: PRESTO
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Alopecia Areata
Interventions: DRUG: Ritlecitinib
Sponsor: Pfizer
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-08
Completion Date: 2027-12-31
Locations: Dermatology of Boca, Boca Raton, Florida, 33431, United States|Michigan Dermatology Institute, Waterford, Michigan, 48328, United States

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.

Primary Outcome Measures: Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24, SALT score is used to calculate the severity of alopecia areata. Physician calculate it by summing the percentage of hair loss in different regions of scalp., 24 weeks from initiation of the treatment
Secondary Outcome Measures: Demographic characteristic of participants: Age, sex, race, ethnicity, socio-economic status, area of residence, smoking status, Number/percentage of patients by age, sex, race, ethnicity, socio-economic status, area of residence, smoking status, Baseline|Demographic Characteristic of Participants: Date of Initial AA diagnosis, Baseline|Demographic Characteristics of participants: Duration of AA since diagnosis, Baseline|Demographic characteristics of participants: Duration of current AA Episode, Baseline|Demographic Characteristic of Participants: Predominant AA phenotype, Predominant AA phenotype (eg, patchy; ophiasis; AT; AU, etc, Baseline|Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score, SALT score is used to calculate the severity of alopecia areata., Baseline|Clinical characteristics of participants: Eyelash Assessment (ELA) score, ELA score is used to calculate the severity of the involvement of eyelashes., Baseline|Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score, EBA score is used to calculate the severity of the involvement of eyebrows, Baseline|Clinical Characteristics of participants: number of affected nails, Baseline|Clinical Characteristics of participants: Presence of Beard involvement, Determine whether the beard is affected or not., Baseline|AA treatment history of participants: number of patients with prior AA treatments, Baseline|AA treatment history of participants: prior AA treatment class and route, Baseline|AA treatment history of participants: duration of prior therapy / frequency, baseline|AA treatment history of the participants: total number of prior AA treatments, Baseline|RW effectiveness of ritlecitinib: proportion of patients with <20 in SALT score, decrease in SALT score is the indicator of effectiveness., week 24, 48, 72 and 96|RW effectiveness of ritlecitinib: Proportion of patients with <10, Decrease in SALT score is the indicator of effectiveness, week 24, 48, 72 and 96|RW effectiveness of ritlecitinib: Change from baseline in SALT score, Decrease in SALT score is the indicator of effectiveness, week 24, 48, 72 and 96|RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyebrow Assessment score (EBA), Improvement in EBA score will indicate ritlecitinib effectiveness in eyebrow involvement., Week 24, 48, 72 and 96|RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyelashes Assessment Score (ELA), Improvement in ELA score will indicate ritlecitinib effectiveness in eyebrow involvement., Week 24, 48, 72 and 96|RW effectiveness of ritlecitinib: proportion of patients with improvement from abnormal baseline in beard assessment and nail involvement, week 24, 48, 72 and 96|Patient reported outcome: Evaluate ritlecitinib treatment satisfaction, Patient-reported satisfaction (P-sat) Response (defined as slightly, moderately, or very satisfied) at 24, 48, 72 and 96 weeks, week 24, 48, 72 and 96|Patient reported outcome: Evaluate impression of hair growth, Patient Global Impression of Change (PGI-C) Response (defined as a score of moderate to severe), at 24, 48, 72 and 96 weeks, week 24, 48, 72 and 96|Evaluate impact of ritlecitinib: Patient reported quality of life, Changes in AAPPO. · Improvement in hair loss AAPPO items 1-4, defined as a score of 0="no hair loss" or

1=" little hair loss", among patients with a baseline score 2-4 indicating moderate-complete hair loss., week 24, 48, 72 and 96|Evaluate impact of ritlecitinib: Patient reported quality of life, Change from baseline in emotional symptoms (ES) and activity limitations (AL) subscores, week 24, 48, 72 and 96