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NCT Number: NCT07821216

Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data

This study will use US electronic health records (EHR) linked to US healthcare claims data to describe the baseline demographic and clinical characteristics of AA patients prescribed ritlecitinib; assess its real-world effectiveness based on dermatologist-recorded outcomes; and evaluate ritlecitinib treatment patterns and concomitant use of SOC (Standard of care) medications among patients aged 12 years and older.

Data Management All study data exist as structured data by the time of study. ModMed structured EHR data will be delivered to HealthVerity. HealthVerity will then normalize the data to comply with HealthVerity's HIPAA Certification and Expert Determination. HealthVerity will then deliver the transformed ModMed data to the sponsor's de-identified environment. HealthVerity also will deliver structured claims data to the sponsor's de-identified environment. The sponsor will then link the claims data with the transformed ModMed data. The sponsor will conduct data analyses using SAS (SAS Institute, Cary, NC, US) or R (The R Foundation for Statistical Computing, Vienna, Austria). Versions of packages will be documented to assure reproducibility. Analyses will extract data according to all details in the study design, e.g., inclusion and exclusion criteria.

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  • ≥1 ritlecitinib prescription fill after 23 June 2023; the date of the first prescription fill is the index date, provided criterion 2 below is satisfied.

1.1. ≥1 ModMed AA diagnosis on or within 365 days before the index date, identified using diagnosis-related variables (defined in the SAP) as well as any of the following ICD-10-CM codes:

  • L63.0: alopecia (capitis) totalis
  • L63.1: alopecia universalis
  • L63.2: ophiasis
  • L63.8: other alopecia areata
  • L63.9: alopecia areata, unspecified 1.2. Age ≥12 years on the index date. Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

  • ≥ 2 of the same diagnoses in the data source of other types of alopecia or diseases that can cause hair loss (e.g., androgenetic alopecia, traction and scarring alopecia, telogen effluvium) in the 365 days before the index date.

Treatment and study plan

Ritlecitinib

Drug

As provided in real world practice

Other names: Litfulo

Primary outcomes

  1. Patient Outcome Measure: Counts and proportions of study participants in each SALT score category

    Time frame: Baseline

    Overall and for each stratifying variable.

  2. Patient Outcome Measure: Change and mean percentage change in SALT scores from baseline

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

    Overall and for each stratifying variable.

  3. Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of ≤20,

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

  4. Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of ≤10,

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

  5. Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of ≤5,

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

  6. Patient Outcome Measure: Percentage of patients with SALT scores >20 at baseline who first achieve SALT scores of 0,

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

Secondary outcomes

  1. Patient demographics and characteristics: race

    Time frame: Baseline

    number of AA patients prescribed ritlecitinib in the real-world in the US

  2. Patient demographics and characteristics: age at index date

    Time frame: Baseline

    Number of percentages of patients by age at index date

  3. Patient demographics and characteristics: sex

    Time frame: Baseline

    Number of percentages of patients by sex

  4. Patient demographics and characteristics: ethnicity

    Time frame: Baseline

    Number of percentages of patients by ethnicity

  5. Patient pre-index clinical characteristic: AA duration of disease

    Time frame: Baseline

  6. Patient clinical characteristic: AA body locations

    Time frame: Baseline

  7. Patient clinical characteristics and outcome: Physician assessment

    Time frame: Baseline through 144 weeks

  8. Patient clinical characteristics: progressors

    Time frame: Baseline

    Among those with a PA assessment in the 45 days before index, yes = those with an assessment consistent with worsening AA; no = those with an assessment consistent with a stable or improving AA assessment.

  9. Patient clinical characteristics: comorbidities

    Time frame: Baseline

  10. Patient clinical characteristics: JAKi exposure

    Time frame: Baseline

    Any prescribed JAKi inhibitor before index date.

  11. Patient clinical characteristics: Standard of care treatments

    Time frame: Baseline through 144 weeks

    Pre-index and concomitant standard of care treatments other than ritlecitinib

  12. Patient Outcome Measure: Ritlecitinib persistence

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

    Among those with ≥ 183 days of continuous enrollment post-index date. Continuous: number of ritlecitinib days' supply (will be reported as months where 30.4 days = 1 month; months range = ~0.5 to ~36) up to the earliest of: a gap of 90+ days in ritlecitinib days' supply; end of continuous enrollment (a gap in enrollment lasting ≥ 45 days); last day of data availability.

  13. Patient Outcome Measure: Ritlecitinib adherence

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

    Among those with ≥ 183 days of continuous enrollment post-index date.

  14. Patient Outcome Measure: Augmenting ritlecitinib with concomitant treatment

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

    Among those with ≥ 183 days of continuous enrollment post-index date. Binary for each SOC treatment class in each follow-up window: yes/no.

  15. Patient Outcome Measure: Treatment switching

    Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

    Among those with ≥ 183 days of continuous enrollment post-index date. Binary for each SOC treatment class, and for the JAKi treatment class, in each follow-up window: yes/no.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 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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