Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib (PRESTO)

PRESTO - Characterization and Clinical Outcomes of Alopecia Aerata (AA) Patients Treated With Ritlecitinib in a Real-world (RW) Cohort: A Multinational, Prospective Observational Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Ritlecitinib

• Study Type: Observational
• Enrollment (Estimated): 850

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• China
  • Beijing, China, 100034
    • Recruiting
    • Peking University First Hospital
  • Beijing, China, 100044
    • Recruiting
    • Peking University People's Hospital
  • Beijing, China, 100006
    • Recruiting
    • Beijing Tongren Hospital
  • Changchun, China, 130021
    • Not yet recruiting
    • The Fist Hospital of Jilin Province
  • Changsha, China, 410028
    • Recruiting
    • Xiangya Hospital, Central South University
  • Guangzhou, China, 510091
    • Recruiting
    • Dermatology Hospital of Southern Medical University
  • Shanghai, China, 200040
    • Recruiting
    • Huashan Hospital affiliated to Fudan University
  • Shanghai, China, 200443
    • Recruiting
    • Shanghai skin disease hospital
• France
  • Argenteuil, France, 95100
    • Not yet recruiting
    • CH Victor Dupouy
  • Caen, France, 14033
    • Recruiting
    • CHU de Caen
  • Dijon, France, 21000
    • Not yet recruiting
    • CHU Dijon Bourgogne
  • La Tronche, France, 38700
    • Not yet recruiting
    • CHU de Grenoble Alpes
  • Rennes, France, 35000
    • Not yet recruiting
    • CHU de Rennes Hôpital Pontchaillou
  • Rouen, France, 76000
    • Recruiting
    • Rouen University Hospital
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75010
      • Not yet recruiting
      • Centre Sabouraud
• Japan
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 807-8556
      • Recruiting
      • Hospital of the University of Occupational and Environmental Health
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Recruiting
      • Kurume University Hospital
  • Kanagawa
    • Ebina, Kanagawa, Japan, 243-0432
      • Recruiting
      • Nagomi Dermatology Clinic
  • Miyagi
    • Sendai, Miyagi, Japan, 908-8574
      • Not yet recruiting
      • Tohoku University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Recruiting
      • Niigata University Medical & Dental Hospital
  • Osaka
    • Osaka, Osaka, Japan, 545-0051
      • Recruiting
      • Osaka Metropolitan University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Recruiting
      • Hamamatsu University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Recruiting
      • Juntendo University Hospital
    • Itabashi-Ku, Tokyo, Japan, 173-8606
      • Not yet recruiting
      • Teikyo University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 160-0023
      • Not yet recruiting
      • Tokyo Medical University Hospital
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Recruiting
    • Royal United Hospital Bath
  • Glasgow, United Kingdom, G4 0SF
    • Recruiting
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom, SW10 9NH
    • Recruiting
    • Chelsea and Westminster NHS Foundation Trust
  • London, United Kingdom, E11 1NR
    • Recruiting
    • Whipps Cross (Barts Health)
  • London, United Kingdom, NW10 7NS
    • Recruiting
    • London North West University Healthcare Trust
  • EAST Sussex
    • Brighton, EAST Sussex, United Kingdom, BN2 3EW
      • Not yet recruiting
      • University Hospitals Sussex
  • FIFE
    • Dunfermline, FIFE, United Kingdom, KY120SU
      • Not yet recruiting
      • NHS Fife
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL13PX
      • Recruiting
      • Gloucestershire Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • Recruiting
      • C2 Research Center
  • California
    • Fremont, California, United States, 94538
      • Recruiting
      • CENTER FOR DERMATOLOGY CLINICAL RESEARCH, Inc
    • Fresno, California, United States, 93720
      • Recruiting
      • Rao Dermatology
    • Oxnard, California, United States, 93030
      • Recruiting
      • Cura Clinical Research
    • Redwood City, California, United States, 94063
      • Not yet recruiting
      • Stanford
    • Santa Ana, California, United States, 92701
      • Recruiting
      • Southern California Clinical Research
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Recruiting
      • Dermatology of Boca
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • Pediatric Skin Research,LLC
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Suncoast Skin Solutions
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
    • Miami, Florida, United States, 33173
      • Recruiting
      • Skin Research of South Florida LLC
  • Maryland
    • Marriottsville, Maryland, United States, 21104
      • Recruiting
      • Kindred Hair and Skin Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital/Harvard Medical School
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • Recruiting
      • Oakland Hills Dermatology
    • Waterford, Michigan, United States, 48328
      • Recruiting
      • Michigan Dermatology Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Active, not recruiting
      • Twin Cities Dermatology Center
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • Recruiting
      • Hickory Dermatology Research Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • NW Dermatology Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Recruiting
      • Goodlettsville Dermatology Research
  • Texas
    • Southlake, Texas, United States, 76092
      • Recruiting
      • Epiphany Dermatology
  • Virginia
    • Fairfax, Virginia, United States, 22033
      • Recruiting
      • Raven Clinical Reseach
    • McLean, Virginia, United States, 22102
      • Recruiting
      • Raven Clinical Reseach
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Recruiting
      • Frontier Dermatology
  • Wisconsin
    • Burlington, Wisconsin, United States, 53105
      • Recruiting
      • Raven Clinical Reseach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Male and female patients aged >12 years at baseline.
2. 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.
3. 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.
4. 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:

1. 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).
2. 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.
3. Patients previously treated with ritlecitinib or other JAK inhibitors.
4. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alopecia Areata (AA) patients treated with ritlecitinib	Drug: Ritlecitinib; As provided in the real world practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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.	Baseline

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin and Connective Tissue Diseases; Alopecia Areata
• Other Study ID Numbers: B7981105; NCT06531109 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.