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Alopecia AreataNCT07226531

Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Alopecia areata (AA) is a chronic, relapsing T-cell mediated autoimmune disease characterized by nonscarring, typically patchy hair loss that affects people of all ages, races, and genders. In the United States (US), AA has an estimated point prevalence of 1.14% (Beningo et al., 2020). 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
300 participants
Where
1 siteUnited States
Study dates
22 Dec 2025to 6 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

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: The study will include patients with severe AA who initiated ritlecitinib (for treatment of severe AA) at least 6 months before the start of data collection. The study assumes that treatment with ritlecitinib was per label, as indicated for severe AA among patients at least 12 years of age. Data collection will be led by physicians (or their designated clinical assistants and staff, including nurse practitioners and physician assistants) recruited to the study who specialize in dermatology and are experienced in managing patients with AA.

Who may be able to join

  • Confirmed diagnosis of severe AA (as determined by the treating physician)
  • Initiated ritlecitinib for severe AA between 01 July 2023 and 28 February 2025
  • At least 12 years of age at ritlecitinib initiation
  • Has at least one additional follow-up visit/consultation after ritlecitinib initiation in which scalp hair loss was assessed
  • Has a complete medical record regarding management or treatment of AA, covering the period initial AA diagnosis until their most recent follow-up/consultation

Who cannot join

  • Ever diagnosed with other types of alopecia (i.e., e.g., chemotherapy-induced alopecia, androgenic alopecia [i.e., male pattern baldness], cicatricial alopecia [i.e., scarring alopecia], postpartum alopecia, or traction alopecia), other diseases (besides AA) that can cause hair loss, or other diseases that could interfere with assessment of hair loss/regrowth
  • No documentation in the medical record of percent of scalp hair loss
  • Participated in any clinical trial involving treatment with ritlecitinib, baricitinib, deuruxolitinib, delgocitinib, brepocitinib, or upadacitinib

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: RETROSPECTIVE COHORT STUDY TO ASSESS UTILIZATION AND EFFECTIVENESS OF RITLECITINIB IN A REAL-WORLD POPULATION WITH SEVERE ALOPECIA AREATA IN THE UNITED STATES

Alopecia areata (AA) is a chronic, relapsing T-cell mediated autoimmune disease characterized by nonscarring, typically patchy hair loss that affects people of all ages, races, and genders. In the United States (US), AA has an estimated point prevalence of 1.14% (Beningo et al., 2020). The three most common subtypes of AA are defined by the affected area:

  • Patchy alopecia (PA), as seen in 90% of clinical diagnoses: hair loss occurring in one or more patches (ranging from coin-sized to large patches and even full scalp involvement) on the scalp or other parts of the body;
  • Alopecia totalis (AT): loss of all or nearly all scalp hair;
  • Alopecia universalis (AU): loss of all or nearly all scalp, face, and body hair Traditionally, a range of medications, including corticosteroids, immunotherapy, and minoxidil, are used to treat AA. However, few of these mainstay therapies are supported by robust clinical evidence, limiting the development of widely accepted clinical practice guidelines (Asfour et al., 2023). As a result of suboptimal effectiveness of traditional therapies, patients with AA, particularly those with extensive hair loss, have a persistent unmet medical need. Furthermore, the potential effects of AA on other subgroups, including patients with skin of color, remain undefined. As these subgroups have been historically underrepresented in clinical trials, an additional unmet medical need and evidence gap exists for these patients.
Read more

Recent clinical studies have demonstrated efficacy of novel treatments for AA, including ritlecitinib, a JAK3/TEC family kinase inhibitor developed and marketed by Pfizer (King et al., 2023). Ritlecitinib was approved by the US Food and Drug Administration (FDA) in June 2023 for the treatment of severe AA in adults and adolescents aged 12 years or older. Extensive information from clinical trials exists on the safety and efficacy of ritlecitinib, which, along with JAK inhibitors such as baricitinib and deuruxolitinib that are FDA approved for severe alopecia areas in adults 18 and over, have presented needed new therapeutic options for these patients. However, little is known about the clinical effectiveness of ritlecitinib in real-world clinical practice.

The objective of the current study is to evaluate patient characteristics, treatment patterns and related clinical outcomes of patients who initiated ritlecitinib to treat severe AA.

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

    As provided in real-world practice

Study groups in NCT07226531
Study groupRoleWhat they receive
Alopecia areata (AA) patients treated with ritlecitinibNot described
Receives: Drug: Ritlecitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient demographics characteristics: race

    Number of percentages of patients by race

    Measured: Baseline

  2. Patient demographics characteristics: sex, age at initial AA diagnosis, geographic location of patient's treating dermatologist, insurance type

    Number of percentages of patients by sex

    Measured: "Baseline" or "Day 1"

  3. Patient demographics characteristics: age at initial AA diagnosis

    Number of percentages of patients by age at initial AA diagnosis

    Measured: "Baseline" or "Day 1"

  4. Patient demographics characteristics: geographic location of patient's treating dermatologist

    Number of percentages of patients by geographic location of patient's treating dermatologist

    Measured: "Baseline" or "Day 1"

  5. Patient demographics characteristics: insurance type

    Number of percentages of patients by insurance type

    Measured: "Baseline" or "Day 1"

  6. Patient clinical characteristics at initial AA diagnosis: AA disease activity

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA disease activity

    Measured: "Baseline" or "Day 1"

  7. Patient clinical characteristics at initial AA diagnosis: SALT score

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: SALT score

    Measured: "Baseline" or "Day 1"

  8. Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: dermatology life quality index (DLQI) score

    Measured: "Baseline" or "Day 1"

  9. Patient clinical characteristics at initial AA diagnosis: eyebrow involvement

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyebrow involvement

    Measured: "Baseline" or "Day 1"

  10. Patient clinical characteristics at initial AA diagnosis: eyelash involvement

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: eyelash involvement

    Measured: "Baseline" or "Day 1"

  11. Patient clinical characteristics at initial AA diagnosis: beard involvement

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: beard involvement

    Measured: "Baseline" or "Day 1"

  12. Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations

    Number of percentages of Patient clinical characteristics at initial AA diagnosis: AA involvement at other body locations

    Measured: "Baseline" or "Day 1"

  13. Patient treatment history: Additional treatment classes received during ritlecitinib treatment, additional treatment classes received after discontinuation of ritlecitinib, duration of each treatment class

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  14. Characteristics of ritlecitinib treatment: Total duration of ritlecitinib exposure, reasons for ritlecitinib discontinuation (if ritlecitinib treatment stopped before last known clinic visit),

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  15. Real-world clinical outcomes of ritlecitinib treatment: AA disease activity

    AA disease activity reported as active hair loss or inactive hair loss

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  16. Real-world clinical outcomes of ritlecitinib treatment: SALT score overall change from baseline

    SALT score overall change from baseline (i.e., to last observed clinic visit), as well as change from baseline to predefined post-index time points (6-, 12-, 18-, and 24-months post-index, or other relevant timepoints based on actual distribution of data). Numeric and Categorical Data: no reduction from baseline, >0%-≤25% SALT reduction, >25%-≤50% SALT reduction, >50%-≤75% SALT reduction, >75% SALT reduction; Yes/No indicator for ≥30% SALT reduction; other categories/thresholds may also be applied.

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  17. Real-world clinical outcomes of ritlecitinib treatment: SALT score

    Numeric data, with categorical values of <50. 50-75, 75-100, and additional categories for ≥50 (to define severe AA) and 95-100 (to defined very severe AA); alternative categories may also be applied.

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  18. Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving SALT ≤20 and ≤10

    Landmark probabilities of achieving SALT≤20 and SALT≤10 at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data.

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  19. Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving a sustained SALT response

    Landmark probabilities of achieving a sustained SALT response at 6-, 12-, 18-, and 24-months post-index date, or other relevant timepoints based on actual distribution of data

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  20. Real-world clinical outcomes of ritlecitinib treatment: landmark probabilities of achieving ≥30% SALT score reduction from baseline at 6-, 12-, 18-, and 24-months post-index date

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  21. Real-world clinical outcomes of ritlecitinib treatment: beard involvement

    Categorical; none; minimal bear hair loss; moderate beard hair loss; severe beard hair loss; very severe or complete beard hair loss

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  22. Real-world clinical outcomes of ritlecitinib treatment: eyebrow and eyelash involvement

    Categorical data with values of 0 (no involvement), 1 (minimal gaps), 2 (significant gaps), or 3 (complete loss)

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  23. Real-world clinical outcomes of ritlecitinib treatment: AA involvement at other body locations

    Yes/no indicator for involvement at each of the following body sites: Extremities (arms, hands, legs, feet); Torso (chest, back, stomach); Pubic areas; Nasal hair; Nails

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  24. Real-world clinical outcomes of ritlecitinib treatment: DLQI score

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  25. Real-world clinical outcomes of ritlecitinib treatment: Patient report of feeling embarrassed or self-conscious because of AA

    Yes; no; as documented by the physician at each clinic visit in the post-index date period

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  26. Real-world clinical outcomes of ritlecitinib treatment: DLQI score overall change from baseline

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  27. Real-world clinical outcomes of ritlecitinib treatment: patient report of AA affecting social or leisure activities

    Yes; no; as documented by the physician at each clinic visit in the post-index date period

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

  28. Real-world clinical outcomes of ritlecitinib treatment: mental health comorbidities present at last known clinic visit

    Yes; No; indicators for presence of specific psychiatric disorders examined in a prior systematic literature review by Lee et al. (2019)

    Measured: "Day 1 through study completion, a minimum of 6-months follow-up"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2025
  2. Study start22 Dec 2025
  3. Primary completion6 Mar 2026
  4. Study completion6 Mar 2026

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07226531
Sponsor's protocol ID
B7981121
Status last verified
Aug 2026
First submitted
22 Sep 2025
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
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.

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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 demographics characteristics: race (time frame: Baseline). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Aug 2026.

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