Litfulo Capsules Special Investigation

Active, not recruiting

• Conditions: Alopecia Areata
• Interventions: Drug: LITFULO

• Registration Number: NCT06279221
• Lead Sponsor: Pfizer

Brief Summary

The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.

Detailed Description

This study is an open-label, multi-center, one arm prospective observational cohort study of patients receiving this drug. The investigators complete the CRF based on the information extracted from the medical record created in daily medical practice.

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-28
• Study Start: 2024-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2030-06-25
• Study Completion: 2030-06-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

• Patients with alopecia areata who start receiving this drug for the first time after the contract date of this study
• Patients who have not participated in a clinical trial (clinical study) of this drug

Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

• Patients previously enrolled in this study
• Patients with a history of treatment with this drug (including investigational product)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Japanese participants with alopecia areata	LITFULO	Japanese participants with alopecia areata

Primary Outcome Measures

Name	Time	Method
Proportion of participants with adverse events (AEs)	Baseline through year 3
Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less]	Baseline, evaluation at Week 12, Week 24 , Week 48, Week 78 , Week 104 , Week 130 , and Week 156 after the start of administration.	The percentage of patients who achieved SALT ≤ 20 (absolute SALT score of ≤ 20) will be calculated at baseline (including the first day of treatment) and each evaluation time point after the start of treatment with this drug.

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan