Alopecia AreataNCT07821216
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
An observational study of Alopecia Areata, run by Pfizer at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- ritlecitinib
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2026to 20 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- 1. ≥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
Show all 10Show fewer
- 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:
- 1. ≥ 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alopecia Areata
- Being tested
- ritlecitinib
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ritlecitinibDrug
Also called Litfulo
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ritlecitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Outcome Measure: Counts and proportions of study participants in each SALT score category
Overall and for each stratifying variable.
Measured: Baseline
Patient Outcome Measure: Change and mean percentage change in SALT scores from baseline
Overall and for each stratifying variable.
Measured: 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,
Measured: 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,
Measured: 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,
Measured: 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,
Measured: Week 24; week 48; week 72; week 96; week 120; week 144
Secondary outcomes (15)
Patient demographics and characteristics: race
number of AA patients prescribed ritlecitinib in the real-world in the US
Measured: Baseline
Patient demographics and characteristics: age at index date
Number of percentages of patients by age at index date
Measured: Baseline
Patient demographics and characteristics: sex
Number of percentages of patients by sex
Measured: Baseline
Patient demographics and characteristics: ethnicity
Number of percentages of patients by ethnicity
Measured: Baseline
Patient pre-index clinical characteristic: AA duration of disease
Measured: Baseline
Patient clinical characteristic: AA body locations
Measured: Baseline
Patient clinical characteristics and outcome: Physician assessment
Measured: Baseline through 144 weeks
Patient clinical characteristics: progressors
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.
Measured: Baseline
Patient clinical characteristics: comorbidities
Measured: Baseline
Patient clinical characteristics: JAKi exposure
Any prescribed JAKi inhibitor before index date.
Measured: Baseline
Patient clinical characteristics: Standard of care treatments
Pre-index and concomitant standard of care treatments other than ritlecitinib
Measured: Baseline through 144 weeks
Patient Outcome Measure: Ritlecitinib persistence
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.
Measured: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Ritlecitinib adherence
Among those with ≥ 183 days of continuous enrollment post-index date.
Measured: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Augmenting ritlecitinib with concomitant treatment
Among those with ≥ 183 days of continuous enrollment post-index date. Binary for each SOC treatment class in each follow-up window: yes/no.
Measured: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Treatment switching
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.
Measured: Week 24; week 48; week 72; week 96; week 120; week 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start17 Aug 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821216
- Sponsor's protocol ID
- B7981135
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.