NCT07152119

A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.

Korean Post Marketing Surveillance for Litfulo Capsule

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

To evaluate the safety of Litfulo Capsule after marketing, with regard to the following clauses in routine clinical practice. * Adverse Events (AEs)/ Adverse Drug Reactions (ADRs) * Unexpected Adverse Events (AEs)/ADRs that have not been reflected in the approved drug label * Serious Adverse Events (SAEs)/Serious Adverse Drug Reaction (SADRs) * Adverse Event of Special Interest(AESI) * Serious Infections, defined as any infection (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy or hospitalization for treatment or meeting other criteria that require the infection to be classified as serious adverse event * Opportunistic infections and Herpes Zoster * Malignancy

Conditions

• Severe Alopecia Areata

Interventions

Type	Name	Description
DRUG	Litfulo	as provided in real world practice.

Timeline

• Start date: 2025-08-27
• Primary completion: 2030-03-23
• Completion: 2030-03-23
• First posted: 2025-09-03
• Last updated: 2025-11-20

Locations

1 site across 1 country: South Korea