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

NCT07226531 | Recruiting

• 1 other identifier: B7981121
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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). 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. 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

Outcome Measures

Primary Outcomes (28)

• Patient demographics characteristics: race

  Number of percentages of patients by race

  Baseline

• 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

  "Baseline" or "Day 1"

• Patient demographics characteristics: age at initial AA diagnosis

  Number of percentages of patients by age at initial AA diagnosis

  "Baseline" or "Day 1"

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

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

  "Baseline" or "Day 1"

• Patient demographics characteristics: insurance type

  Number of percentages of patients by insurance type

  "Baseline" or "Day 1"

• Patient clinical characteristics at initial AA diagnosis: AA disease activity

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

  "Baseline" or "Day 1"

• Patient clinical characteristics at initial AA diagnosis: SALT score

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

  "Baseline" or "Day 1"

• 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

  "Baseline" or "Day 1"

• Patient clinical characteristics at initial AA diagnosis: eyebrow involvement

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

  "Baseline" or "Day 1"

• Patient clinical characteristics at initial AA diagnosis: eyelash involvement

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

  "Baseline" or "Day 1"

• Patient clinical characteristics at initial AA diagnosis: beard involvement

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

  "Baseline" or "Day 1"

• 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

  "Baseline" or "Day 1"

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

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

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

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

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

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

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

• 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.

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

• 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.

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

• 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.

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

• 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

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

• 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

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

• 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

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

• 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)

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

• 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

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

• Real-world clinical outcomes of ritlecitinib treatment: DLQI score

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

• 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

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

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

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

• 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

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

• 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)

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

Study Arms (1)

Alopecia areata (AA) patients treated with ritlecitinib

Drug: Ritlecitinib

Interventions

Ritlecitinib DRUG

As provided in real-world practice

Alopecia areata (AA) patients treated with ritlecitinib

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

RECRUITING

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

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

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

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 10, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)