PRESTO - CHARACTERIZATION AND CLINICAL OUTCOMES OF ALOPECIA AREATA (AA) PATIENTS TREATED WITH RITLECITINIB IN A REAL-WORLD (RW) COHORT: A MULTINATIONAL, PROSPECTIVE OBSERVATIONAL STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 450
- 试验地点
- 70
- 主要终点
- Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Alopecia Areata (AA) patients treated with ritlecitinib
干预措施: Ritlecitinib (Drug)
结局指标
主要结局
Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24
时间窗: 24 weeks from initiation of the treatment
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.
次要结局
- Evaluate impact of ritlecitinib: Patient reported quality of life(week 24, 48, 72 and 96)
- Demographic characteristic of participants: 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(Baseline)
- Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score(Baseline)
- Clinical characteristics of participants: Eyelash Assessment (ELA) score(Baseline)
- Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score(Baseline)
- Clinical Characteristics of participants: number of affected nails(Baseline)
- Clinical Characteristics of participants: Presence of Beard involvement(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(week 24, 48, 72 and 96)
- RW effectiveness of ritlecitinib: Proportion of patients with <10(week 24, 48, 72 and 96)
- RW effectiveness of ritlecitinib: Change from baseline in SALT score(week 24, 48, 72 and 96)
- RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyebrow Assessment score (EBA)(Week 24, 48, 72 and 96)
- RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyelashes Assessment Score (ELA)(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(week 24, 48, 72 and 96)
- Patient reported outcome: Evaluate impression of hair growth(week 24, 48, 72 and 96)