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NCT Number: NCT07152119

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

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.

Recruiting

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LITFULO

Drug

as provided in real world practice.

Other names: Ritlecitinib tosylate (ATC code: L04AF08)

Primary outcomes

  1. Frequency and proportion of AEs/ADRs

    Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)

  2. Frequency and proportion of unexpected AEs/ADRs

    Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)

  3. Frequency and proportion of SAEs/SADRs

    Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)

  4. Frequency and proportion of AESI

    Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)

Secondary outcomes

  1. 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)

  2. Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48

    Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)

  3. 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)

  4. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

KOREAN POST MARKETING SURVEILLANCE FOR LITFULO CAPSULE

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 3, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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