Litfulo Capsules Special Investigation | NCT06279221

Studies
Litfulo Capsules Special Investigation

NCT06279221

Sponsor

Pfizer

Status

Active, not recruiting

Last Update Posted

Mar 2, 2026Actual

Enrollment

487Actual

Phase

Not provided

Conditions

Alopecia Areata

Interventions

LITFULO

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCT06279221	Registry Identifier	ClinicalTrials.gov

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Apr 24, 2030Estimated

Completion Date

Apr 24, 2030Estimated

First Submitted Date

Feb 19, 2024

First Submission Date that Met QC Criteria

Feb 19, 2024

First Posted Date

Feb 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2026

Last Update Posted Date

Mar 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

487Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Japanese participants with alopecia areata		Japanese participants with alopecia areata	Drug: LITFULO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LITFULO	Drug	as provided in real world practice	Japanese participants with alopecia areata

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of participants with adverse events (AEs)		Baseline through year 3
Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less]	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with alopecia areata who received LITFULO

Sampling Method

Probability Sample

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

ID	Term
D000505	Alopecia
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases