An observational study in Severe Alopecia Areata, sponsored by Pfizer. Recruiting at 1 site in South Korea. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Pfizer · Observational
The purpose of this observation study is to learn about the safety and effects of the study medicine (called Litfulo) for the potential treatment of Severe Alopecia Areata.
To evaluate the safety of Litfulo Capsule after marketing, with regard to the following clauses in routine clinical practice.
Adverse Event of Special Interest(AESI)
467 studies on the registry are indexed under Alopecia Areata; 92 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 215 across 59 observational studies indexed under Alopecia Areata.
Browse Alopecia Areata studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with severe alopecia areata
Inclusion Criteria:
Patients with severe alopecia areata who have been determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product Treatment of severe alopecia areata in adults and adolescents 12 years or older Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study
Determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product.
Drug: Litfulo
as provided in real world practice.
Also known as: Ritlecitinib tosylate (ATC code: L04AF08)
Frequency and proportion of AEs/ADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of unexpected AEs/ADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of SAEs/SADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of AESI
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving Severity of Alopecia Tool (SALT) ≤20 score at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving 50% or above improvement in SALT score from baseline (SALT 50) at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving 75% or above improvement in SALT score from baseline (SALT 75) at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Plan to share: 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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