An observational study in Alopecia Areata, sponsored by Pfizer. Active, not recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Pfizer · Observational
Among 17 studies in Alopecia Areata by Pfizer — 5 open to participants now, 9 under way, 4 of them phase 3. Alopecia Areata · Pfizer.
Among the 17 studies in Alopecia Areata by Pfizer, this one is one of 2 that started in 2026, is one of 6 observational ones, and was the 17th registered.
220 studies on the registry are indexed under Alopecia Areata; 61 are open to participants now.
This study's enrollment of 1 is below the median of 370 across 39 observational studies indexed under Alopecia Areata.
Browse Alopecia Areata studies →5 of the 17 studies in Alopecia Areata by Pfizer are open now, in 12 countries. Each count lists the studies.
Of the 41 Alopecia Areata studies recruiting now, 16 (39%) set no upper age limit and 21 (51%) stop at 75 or younger; 20 take children under 18; 5 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 2 started in 2026.
Median enrollment 175 across the 10 interventional studies, 375 across the 6 observational. Of the 8 that completed or were terminated, 6 (75%) have results posted.
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
2 of the studies in Alopecia Areata by Pfizer that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07029711Phase 3PfizerA Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata | 2026-12-02 |
| NCT07821216PfizerReal-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data | 2026-11-20 |
Among the 17 studies in Alopecia Areata by Pfizer, from their registry updates:
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.
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.
Inclusion Criteria
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:
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.
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
As provided in real world practice
Also known as: Litfulo
Patient Outcome Measure: Counts and proportions of study participants in each SALT score category
Overall and for each stratifying variable.
Time frame: Baseline
Patient Outcome Measure: Change and mean percentage change in SALT scores from baseline
Overall and for each stratifying variable.
Time frame: 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,
Time frame: 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,
Time frame: 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,
Time frame: 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,
Time frame: Week 24; week 48; week 72; week 96; week 120; week 144
Patient demographics and characteristics: race
number of AA patients prescribed ritlecitinib in the real-world in the US
Time frame: Baseline
Patient demographics and characteristics: age at index date
Number of percentages of patients by age at index date
Time frame: Baseline
Patient demographics and characteristics: sex
Number of percentages of patients by sex
Time frame: Baseline
Patient demographics and characteristics: ethnicity
Number of percentages of patients by ethnicity
Time frame: Baseline
Patient pre-index clinical characteristic: AA duration of disease
Time frame: Baseline
Patient clinical characteristic: AA body locations
Time frame: Baseline
Patient clinical characteristics and outcome: Physician assessment
Time frame: 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.
Time frame: Baseline
Patient clinical characteristics: comorbidities
Time frame: Baseline
Patient clinical characteristics: JAKi exposure
Any prescribed JAKi inhibitor before index date.
Time frame: Baseline
Patient clinical characteristics: Standard of care treatments
Pre-index and concomitant standard of care treatments other than ritlecitinib
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 24; week 48; week 72; week 96; week 120; week 144
Plan to share: 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.
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Apr 2027 → Nov 2026 and completion Apr 2027 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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