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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07152119

Enrollment

3000

Registered

2025-09-03

Start date

2025-08-27

Completion date

2030-03-23

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Alopecia Areata

Keywords

Litfulo, Litfulo capsule, Ritlecitinib tosylate

Brief 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

Interventions

DRUGLitfulo

as provided in real world practice.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency and proportion of AEs/ADRs	24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of unexpected AEs/ADRs	24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of SAEs/SADRs	24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of AESI	24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)

Secondary

Measure	Time frame
Proportion of patients achieving Severity of Alopecia Tool (SALT) ≤20 score at Weeks 24 and 48	24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48	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	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	24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)

Countries

South Korea

Contacts

CONTACTPfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026