NCT07152119

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Aug 2025Mar 2030

First Submitted

Initial submission to the registry

August 25, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2030

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

4.6 years

First QC Date

August 25, 2025

Last Update Submit

November 17, 2025

Conditions

Severe Alopecia Areata

Keywords

LitfuloLitfulo capsuleRitlecitinib tosylate

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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)

Study Arms (1)

Patients with severe alopecia areata.

Determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product.

Drug: Litfulo

Interventions

LitfuloDRUG

as provided in real world practice.

Also known as: Ritlecitinib tosylate (ATC code: L04AF08)
Patients with severe alopecia areata.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe alopecia areata

You may qualify if:

  • Patients with severe alopecia areata who have been determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product Treatment of severe alopecia areata in adults and adolescents 12 years or older Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer, Inc

Seoul, South Korea

RECRUITING

Related Links

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 3, 2025

Study Start

August 27, 2025

Primary Completion (Estimated)

March 23, 2030

Study Completion (Estimated)

March 23, 2030

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

KR(1)