An observational study in Alopecia Areata, sponsored by Pfizer. Active, not recruiting at 70 sites in 6 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Pfizer · Observational
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:
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.
467 studies on the registry are indexed under Alopecia Areata; 92 are open to participants now.
This study's planned enrollment of 450 is above the median of 215 across 59 observational studies indexed under Alopecia Areata.
Browse Alopecia Areata studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population eligible for enrollment includes any adult and adolescent patients aged ≥12 years diagnosed with AA who receive at least one dose of ritlecitinib and satisfy the inclusion and exclusion criteria. The study will be open for enrollment for approximately 12 months after the first patient has been enrolled. Depending on the observed enrollment rate, the enrollment period and number of sites may be reassessed and revised during the study. It will be allowed to enroll patients with previous use of topical JAK inhibitors only if there was at least a 4-week wash-out period prior to Baseline Visit
Exclusion Criteria:
Drug: Ritlecitinib
As provided in the real world practice.
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.
Time frame: 24 weeks from initiation of the treatment
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. Race and ethnicity variables will only be collected in participating countries where it is allowed.
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
Predominant AA phenotype (eg, patchy; ophiasis; AT; AU, etc
Time frame: Baseline
Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score
SALT score is used to calculate the severity of alopecia areata.
Time frame: Baseline
Clinical characteristics of participants: Eyelash Assessment (ELA) score
ELA score is used to calculate the severity of the involvement of eyelashes.
Time frame: Baseline
Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score
EBA score is used to calculate the severity of the involvement of eyebrows
Time frame: Baseline
Clinical Characteristics of participants: number of affected nails
Time frame: Baseline
Clinical Characteristics of participants: Presence of Beard involvement
Determine whether the beard is affected or not.
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
AA treatment history of participants: duration of prior therapy / frequency
Time frame: baseline
AA treatment history of the participants: total number of prior AA treatments
Time frame: Baseline
RW effectiveness of ritlecitinib: proportion of patients with <20 in SALT score
decrease in SALT score is the indicator of effectiveness.
Time frame: week 24, 48, 72 and 96
RW effectiveness of ritlecitinib: Proportion of patients with <10
Decrease in SALT score is the indicator of effectiveness
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Week 24, 48, 72 and 96
RW effectiveness of ritlecitinib: proportion of patients with improvement from abnormal baseline in beard assessment and nail involvement
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: week 24, 48, 72 and 96
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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