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NCT Number: NCT06531109

Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tongren Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ritlecitinib

Drug

As provided in the real world practice.

Primary outcomes

  1. Percentage change from baseline in Severity of Alopecia Tool (SALT) score at week 24

    Time frame: 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.

Secondary outcomes

  1. Demographic characteristic of participants: Age, sex, race, ethnicity, socio-economic status, area of residence, smoking status

    Time frame: Baseline

    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.

  2. Demographic Characteristic of Participants: Date of Initial AA diagnosis

    Time frame: Baseline

  3. Demographic Characteristics of participants: Duration of AA since diagnosis

    Time frame: Baseline

  4. Demographic characteristics of participants: Duration of current AA Episode

    Time frame: Baseline

  5. Demographic Characteristic of Participants: Predominant AA phenotype

    Time frame: Baseline

    Predominant AA phenotype (eg, patchy; ophiasis; AT; AU, etc

  6. Clinical Characteristics of participants: Severity of Alopecia Tool (SALT) Score

    Time frame: Baseline

    SALT score is used to calculate the severity of alopecia areata.

  7. Clinical characteristics of participants: Eyelash Assessment (ELA) score

    Time frame: Baseline

    ELA score is used to calculate the severity of the involvement of eyelashes.

  8. Clinical Characteristics of participants: Eyebrow Assessment (EBA) Score

    Time frame: Baseline

    EBA score is used to calculate the severity of the involvement of eyebrows

  9. Clinical Characteristics of participants: number of affected nails

    Time frame: Baseline

  10. Clinical Characteristics of participants: Presence of Beard involvement

    Time frame: Baseline

    Determine whether the beard is affected or not.

  11. AA treatment history of participants: number of patients with prior AA treatments

    Time frame: Baseline

  12. AA treatment history of participants: prior AA treatment class and route

    Time frame: Baseline

  13. AA treatment history of participants: duration of prior therapy / frequency

    Time frame: baseline

  14. AA treatment history of the participants: total number of prior AA treatments

    Time frame: Baseline

  15. RW effectiveness of ritlecitinib: proportion of patients with <20 in SALT score

    Time frame: week 24, 48, 72 and 96

    decrease in SALT score is the indicator of effectiveness.

  16. RW effectiveness of ritlecitinib: Proportion of patients with <10

    Time frame: week 24, 48, 72 and 96

    Decrease in SALT score is the indicator of effectiveness

  17. RW effectiveness of ritlecitinib: Change from baseline in SALT score

    Time frame: week 24, 48, 72 and 96

    Decrease in SALT score is the indicator of effectiveness

  18. RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyebrow Assessment score (EBA)

    Time frame: Week 24, 48, 72 and 96

    Improvement in EBA score will indicate ritlecitinib effectiveness in eyebrow involvement.

  19. RW effectiveness of ritlecitinib: proportion of patient with improvement from abnormal baseline in Eyelashes Assessment Score (ELA)

    Time frame: Week 24, 48, 72 and 96

    Improvement in ELA score will indicate ritlecitinib effectiveness in eyebrow involvement.

  20. 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

  21. Patient reported outcome: Evaluate ritlecitinib treatment satisfaction

    Time frame: week 24, 48, 72 and 96

    Patient-reported satisfaction (P-sat) Response (defined as slightly, moderately, or very satisfied) at 24, 48, 72 and 96 weeks

  22. Patient reported outcome: Evaluate impression of hair growth

    Time frame: week 24, 48, 72 and 96

    Patient Global Impression of Change (PGI-C) Response (defined as a score of moderate to severe), at 24, 48, 72 and 96 weeks

  23. Evaluate impact of ritlecitinib: Patient reported quality of life

    Time frame: week 24, 48, 72 and 96

    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.

  24. Evaluate impact of ritlecitinib: Patient reported quality of life

    Time frame: week 24, 48, 72 and 96

    Change from baseline in emotional symptoms (ES) and activity limitations (AL) subscores

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Acronym: PRESTO

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 31, 2024
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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