Litfulo Capsules Special Investigation

NCT06279221 | Active Not Recruiting

• 2 other identifiers: B7981055NCT06279221
• Study Type: observational
• Target: 487
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Japanese participants with alopecia areata

Japanese participants with alopecia areata

Drug: LITFULO

Interventions

LITFULO DRUG

as provided in real world practice

Japanese participants with alopecia areata

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with alopecia areata who received LITFULO

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): April 24, 2030
• Study Completion (Estimated): April 24, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)