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

NCT07821216 | Active Not Recruiting FDA Drug

• 1 other identifier: B7981135
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (6)

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

  Overall and for each stratifying variable.

  Baseline

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

  Overall and for each stratifying variable.

  Week 24; week 48; week 72; week 96; week 120; week 144

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

  Week 24; week 48; week 72; week 96; week 120; week 144

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

  Week 24; week 48; week 72; week 96; week 120; week 144

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

  Week 24; week 48; week 72; week 96; week 120; week 144

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

  Week 24; week 48; week 72; week 96; week 120; week 144

Secondary Outcomes (15)

• Patient demographics and characteristics: race

  Baseline

• Patient demographics and characteristics: age at index date

  Baseline

• Patient demographics and characteristics: sex

  Baseline

• Patient demographics and characteristics: ethnicity

  Baseline

• Patient pre-index clinical characteristic: AA duration of disease

  Baseline

Study Arms (1)

Ritlecitinib Arm

All included participants must have: a physician-confirmed AA diagnosis, a ritlecitinib prescription fill (the first of which must occur after the date of an AA diagnosis; this first prescription fill date serves as the index date), and be at least 12 years old on the index date. Participants will be followed from the index date until the earliest of: the end of continuous health plan enrollment (defined as the day before a gap of ≥ 45 days in enrollment), or the date of the last available data in the linked dataset. The index date must occur after 23 June 2023.

Drug: ritlecitinib

Interventions

ritlecitinib DRUG

As provided in real world practice

Also known as: Litfulo

Ritlecitinib Arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A physician-confirmed AA diagnosis, a ritlecitinib prescription fill (the first of which must occur after the date of an AA diagnosis; this first prescription fill date serves as the index date), and be at least 12 years old on the index date. Participants will be followed from the index date until the earliest of: the end of continuous health plan enrollment (defined as the day before a gap of ≥ 45 days in enrollment), or the date of the last available data in the linked dataset. The index date must occur after 23 June 2023.

You may qualify if:

• \. ≥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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Links

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

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: September 15, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)