Litfulo Capsules Special Investigation

February 26, 2026 updated by: Pfizer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

487

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Pfizer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with alopecia areata who received LITFULO

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Japanese participants with alopecia areata
Drug: LITFULO
as provided in real world practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with adverse events (AEs)
Time Frame: Baseline through year 3
Baseline through year 3
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.
Baseline, evaluation at Week 12, Week 24 , Week 48, Week 78 , Week 104 , Week 130 , and Week 156 after the start of administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

April 24, 2030

Study Completion (Estimated)

April 24, 2030

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7981055
  • NCT06279221 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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