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NCT Number: NCT07226531

Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US

Alopecia areata (AA) is a chronic, relapsing T-cell mediated autoimmune disease characterized by nonscarring, typically patchy hair loss that affects people of all ages, races, and genders. In the United States (US), AA has an estimated point prevalence of 1.14% (Beningo et al., 2020). The three most common subtypes of AA are defined by the affected area:

* Patchy alopecia (PA), as seen in 90% of clinical diagnoses: hair loss occurring in one or more patches (ranging from coin-sized to large patches and even full scalp involvement) on the scalp or other parts of the body; * Alopecia totalis (AT): loss of all or nearly all scalp hair; * Alopecia universalis (AU): loss of all or nearly all scalp, face, and body hair Traditionally, a range of medications, including corticosteroids, immunotherapy, and minoxidil, are used to treat AA. However, few of these mainstay therapies are supported by robust clinical evidence, limiting the development of widely accepted clinical practice guidelines (Asfour et al., 2023). As a result of suboptimal effectiveness of traditional therapies, patients with AA, particularly those with extensive hair loss, have a persistent unmet medical need. Furthermore, the potential effects of AA on other subgroups, including patients with skin of color, remain undefined. As these subgroups have been historically underrepresented in clinical trials, an additional unmet medical need and evidence gap exists for these patients.

Recent clinical studies have demonstrated efficacy of novel treatments for AA, including ritlecitinib, a JAK3/TEC family kinase inhibitor developed and marketed by Pfizer (King et al., 2023). Ritlecitinib was approved by the US Food and Drug Administration (FDA) in June 2023 for the treatment of severe AA in adults and adolescents aged 12 years or older. Extensive information from clinical trials exists on the safety and efficacy of ritlecitinib, which, along with JAK inhibitors such as baricitinib and deuruxolitinib that are FDA approved for severe alopecia areas in adults 18 and over, have presented needed new therapeutic options for these patients. However, little is known about the clinical effectiveness of ritlecitinib in real-world clinical practice.

The objective of the current study is to evaluate patient characteristics, treatment patterns and related clinical outcomes of patients who initiated ritlecitinib to treat severe AA.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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

Pfizer

New York, 10001, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of severe AA (as determined by the treating physician)
  • Initiated ritlecitinib for severe AA between 01 July 2023 and 28 February 2025
  • At least 12 years of age at ritlecitinib initiation
  • Has at least one additional follow-up visit/consultation after ritlecitinib initiation in which scalp hair loss was assessed
  • Has a complete medical record regarding management or treatment of AA, covering the period initial AA diagnosis until their most recent follow-up/consultation

Exclusion criteria

  • Ever diagnosed with other types of alopecia (i.e., e.g., chemotherapy-induced alopecia, androgenic alopecia [i.e., male pattern baldness], cicatricial alopecia [i.e., scarring alopecia], postpartum alopecia, or traction alopecia), other diseases (besides AA) that can cause hair loss, or other diseases that could interfere with assessment of hair loss/regrowth
  • No documentation in the medical record of percent of scalp hair loss
  • Participated in any clinical trial involving treatment with ritlecitinib, baricitinib, deuruxolitinib, delgocitinib, brepocitinib, or upadacitinib

Treatment and study plan

Ritlecitinib

Drug

As provided in real-world practice

Primary outcomes

  1. Patient demographics characteristics: race

    Time frame: Baseline

    Number of percentages of patients by race

  2. Patient demographics characteristics: sex, age at initial AA diagnosis, geographic location of patient's treating dermatologist, insurance type

    Time frame: "Baseline" or "Day 1"

    Number of percentages of patients by sex

  3. Patient demographics characteristics: age at initial AA diagnosis

    Time frame: "Baseline" or "Day 1"

    Number of percentages of patients by age at initial AA diagnosis

  4. Patient demographics characteristics: geographic location of patient's treating dermatologist

    Time frame: "Baseline" or "Day 1"

    Number of percentages of patients by geographic location of patient's treating dermatologist

  5. Patient demographics characteristics: insurance type

    Time frame: "Baseline" or "Day 1"

    Number of percentages of patients by insurance type

  6. Patient clinical characteristics at initial AA diagnosis: AA disease activity

    Time frame: "Baseline" or "Day 1"

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA disease activity

  7. Patient clinical characteristics at initial AA diagnosis: SALT score

    Time frame: "Baseline" or "Day 1"

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: SALT score

  8. Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score

    Time frame: "Baseline" or "Day 1"

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score

  9. Patient clinical characteristics at initial AA diagnosis: eyebrow involvement

    Time frame: "Baseline" or "Day 1"

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyebrow involvement

  10. Patient clinical characteristics at initial AA diagnosis: eyelash involvement

    Time frame: "Baseline" or "Day 1"

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyelash involvement

  11. Patient clinical characteristics at initial AA diagnosis: beard involvement

    Time frame: "Baseline" or "Day 1"

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: beard involvement

  12. Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations

    Time frame: "Baseline" or "Day 1"

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations

  13. Patient treatment history: Additional treatment classes received during ritlecitinib treatment, additional treatment classes received after discontinuation of ritlecitinib, duration of each treatment class

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

  14. Characteristics of ritlecitinib treatment: Total duration of ritlecitinib exposure, reasons for ritlecitinib discontinuation (if ritlecitinib treatment stopped before last known clinic visit),

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

  15. Real-world clinical outcomes of ritlecitinib treatment: AA disease activity

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    AA disease activity reported as active hair loss or inactive hair loss

  16. Real-world clinical outcomes of ritlecitinib treatment: SALT score overall change from baseline

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    SALT score overall change from baseline (i.e., to last observed clinic visit), as well as change from baseline to predefined post-index time points (6-, 12-, 18-, and 24-months post-index, or other relevant timepoints based on actual distribution of data). Numeric and Categorical Data: no reduction from baseline, >0%-≤25% SALT reduction, >25%-≤50% SALT reduction, >50%-≤75% SALT reduction, >75% SALT reduction; Yes/No indicator for ≥30% SALT reduction; other categories/thresholds may also be applied.

  17. Real-world clinical outcomes of ritlecitinib treatment: SALT score

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Numeric data, with categorical values of <50. 50-75, 75-100, and additional categories for ≥50 (to define severe AA) and 95-100 (to defined very severe AA); alternative categories may also be applied.

  18. Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving SALT ≤20 and ≤10

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Landmark probabilities of achieving SALT≤20 and SALT≤10 at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data.

  19. Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving a sustained SALT response

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Landmark probabilities of achieving a sustained SALT response at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data

  20. Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving ≥30% SALT score reduction from baseline at 6-, 12-, 18-, and 24-months post-index date

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

  21. Real-world clinical outcomes of ritlecitinib treatment: beard involvement

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Categorical; none; minimal bear hair loss; moderate beard hair loss; severe beard hair loss; very severe or complete beard hair loss

  22. Real-world clinical outcomes of ritlecitinib treatment: eyebrow and eyelash involvement

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Categorical data with values of 0 (no involvement), 1 (minimal gaps), 2 (significant gaps), or 3 (complete loss)

  23. Real-world clinical outcomes of ritlecitinib treatment: AA involvement at other body locations

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Yes/no indicator for involvement at each of the following body sites: Extremities (arms, hands, legs, feet); Torso (chest, back, stomach); Pubic areas; Nasal hair; Nails

  24. Real-world clinical outcomes of ritlecitinib treatment: DLQI score

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

  25. Real-world clinical outcomes of ritlecitinib treatment: Patient report of feeling embarrassed or self-conscious because of AA

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Yes; no; as documented by the physician at each clinic visit in the post-index date period

  26. Real-world clinical outcomes of ritlecitinib treatment: DLQI score overall change from baseline

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

  27. Real-world clinical outcomes of ritlecitinib treatment: patient report of AA affecting social or leisure activities

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Yes; no; as documented by the physician at each clinic visit in the post-index date period

  28. Real-world clinical outcomes of ritlecitinib treatment: mental health comorbidities present at last known clinic visit

    Time frame: "Day 1 through study completion, a minimum of 6-months follow-up"

    Yes; No; indicators for presence of specific psychiatric disorders examined in a prior systematic literature review by Lee et al. (2019)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

RETROSPECTIVE COHORT STUDY TO ASSESS UTILIZATION AND EFFECTIVENESS OF RITLECITINIB IN A REAL-WORLD POPULATION WITH SEVERE ALOPECIA AREATA IN THE UNITED STATES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
May 14, 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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