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

Part of paid clinical trials in New York, New York.

Sponsor
Pfizer
Study ID
NCT07226531
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
May 2026
Primary completion
May 29, 2026
Completion
May 29, 2026

Study Design

Enrollment
300 participants (actual)

Arms

  • Arm: Alopecia areata (AA) patients treated with ritlecitinib

Primary Outcome Measure

Patient demographics characteristics: race [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
PfizerNew YorkNew York10001-

Find similar trials in New York, NY

By research site
Pfizer· New York, NY

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