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

NCT ID: NCT07152119

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2030-03-23

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

Conditions

Severe Alopecia Areata

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with severe alopecia areata.

Determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product.

Litfulo

Intervention Type: DRUG

as provided in real world practice.

Interventions

Litfulo

as provided in real world practice.

Intervention Type: DRUG

Other Intervention Names

Ritlecitinib tosylate (ATC code: L04AF08)

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer, Inc

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Pfizer CT.gov Call Center

Role: CONTACT

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B7981084

To obtain contact information for a study center near you, click here.

Other Identifiers

B7981084

Identifier Type: -

Identifier Source: org_study_id