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

Not yet recruiting

• Conditions: Severe Alopecia Areata
• Interventions: Drug: Litfulo

• Registration Number: NCT07152119
• Lead Sponsor: Pfizer

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

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study Start: 2025-09-01
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2030-09-23
• Study Completion: 2030-09-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with severe alopecia areata.	Litfulo	Determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)