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OpenTrials
Active, Not Recruiting

NCT Number: NCT06279221

Litfulo Capsules Special Investigation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

LITFULO

Drug

as provided in real world practice

Primary outcomes

  1. Proportion of participants with adverse events (AEs)

    Time frame: Baseline through year 3

  2. Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less]

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Litfulo® Capsules Special Investigation

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 28, 2024
Registry last updated
Mar 2, 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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