Ritlecitinib for severe alopecia areata in U.S. patients

Retrospective Cohort Study to Assess Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe Alopecia Areata in the United States

This project will see if ritlecitinib helps people aged 12 and older with severe alopecia areata who started the medication in the U.S. between July 2023 and February 2025.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Drugs / interventions: ritlecitinib, baricitinib, deuruxolitinib, delgocitinib, brepocitinib, upadacitinib, chemotherapy, immunotherapy
• Locations: 1 site (New York, New York)
• Trial ID: NCT07226531 on ClinicalTrials.gov

What this trial studies

This is an observational, real-world record-based study of patients with physician-confirmed severe alopecia areata who initiated ritlecitinib between July 1, 2023 and February 28, 2025. Investigators will use clinic medical records and follow-up visits that document percent scalp hair loss to describe treatment patterns, hair regrowth outcomes, and safety in routine care. Eligible participants must be at least 12 years old, have complete medical records from initial AA diagnosis through most recent visit, and have at least one post-initiation hair-loss assessment; patients with other causes of hair loss are excluded. The study is sponsored by Pfizer and uses data from participating U.S. care settings, with a primary location listed as Pfizer in New York.

Who should consider this trial

Good fit: People aged 12 or older in the United States with a physician-confirmed diagnosis of severe alopecia areata who began ritlecitinib between July 1, 2023 and February 28, 2025 and have follow-up visits documenting percent scalp hair loss and complete medical records are ideal candidates.

Not a fit: Patients with other types of hair loss (such as scarring, androgenic, chemotherapy-induced, postpartum, or traction alopecia), those lacking documentation of percent scalp hair loss, or those who did not start ritlecitinib within the specified window are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this project could show how ritlecitinib affects scalp hair coverage in real-world patients with severe alopecia areata and help clinicians and patients make treatment decisions.

How similar studies have performed: Randomized clinical trials of JAK inhibitors, including ritlecitinib and other agents, have shown hair regrowth in alopecia areata, though real-world observational evidence for ritlecitinib is still limited.

Eligibility criteria

Inclusion criteria:

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

Exclusion criteria:

1. 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
2. No documentation in the medical record of percent of scalp hair loss
3. Participated in any clinical trial involving treatment with ritlecitinib, baricitinib, deuruxolitinib, delgocitinib, brepocitinib, or upadacitinib

Where this trial is running

New York, New York

• Pfizer — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Alopecia Areata