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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

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
Are there results?: Not yet: the study is under way

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.

United States1 site

Pfizer
New York, New York, 10001

Other trials in United States

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

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 groups in NCT07821216
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.

17 Aug 202620 Nov 2026

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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07821216
Sponsor's protocol ID: B7981135
Status last verified: Nov 2026
First submitted: 17 Aug 2026
Last updated: 6 Nov 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia

All Alopecia Areata trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REAL-WORLD EFFECTIVENESS OF RITLECITINIB IN ALOPECIA AREATA PATIENTS IN THE US: A RETROSPECTIVE ANALYSIS USING EHR AND CLAIMS DATA
ClinicalTrials.gov ID: NCT07821216
Acronym / sponsor ID: B7981135
Conditions: Alopecia Areata
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 1 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Aug 2026 (actual)
Primary completion: 20 Nov 2026 (estimated)
Study completion: 20 Nov 2026 (estimated)
First posted: 15 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Ritlecitinib Arm	–	Drug: ritlecitinibAll 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.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: 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.

Key inclusion criteria (10 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ritlecitinibAlso: LitfuloAs provided in real world practice	Drug	Ritlecitinib Arm

Primary outcome

Patient Outcome Measure: Counts and proportions of study participants in each SALT score category
Time frame: Baseline
Overall and for each stratifying variable.
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.
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

15 secondary outcomes

Patient demographics and characteristics: race
Time frame: Baseline
Patient demographics and characteristics: age at index date
Time frame: Baseline
Patient demographics and characteristics: sex
Time frame: Baseline
Patient demographics and characteristics: 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
Time frame: Baseline
Patient clinical characteristics: comorbidities
Time frame: Baseline
Patient clinical characteristics: JAKi exposure
Time frame: Baseline
Patient clinical characteristics: Standard of care treatments
Time frame: Baseline through 144 weeks
Patient Outcome Measure: Ritlecitinib persistence
Time frame: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Ritlecitinib adherence
Time frame: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Augmenting ritlecitinib with concomitant treatment
Time frame: Week 24; week 48; week 72; week 96; week 120; week 144
Patient Outcome Measure: Treatment switching
Time frame: Week 24; week 48; week 72; week 96; week 120; week 144

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

Related trials for Alopecia Areata

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Alopecia Areata, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Outcome Measure: Counts and proportions of study participants in each SALT score category (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07821216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.