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NCT06279221 Clinical Trial

Litfulo Capsules Special Investigation

Alopecia Areata Clinical Trial

Official title:
Litfulo® Capsules Special Investigation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06279221
Other study ID # B7981055
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date June 25, 2030

Study information
Verified date June 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 850
Est. completion date June 25, 2030
Est. primary completion date June 25, 2030
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• LITFULO
as provided in real world practice

Locations
Country Name City State
Japan Pfizer Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants with adverse events (AEs) Baseline through year 3
Primary 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.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05051761 - Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata Phase 3
Active, not recruiting NCT03570749 - A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata Phase 2/Phase 3
Completed NCT02812342 - Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants Phase 2
Completed NCT02350023 - Comparison of Topical Latanoprost vs Topical Corticosteroid in Treatment of Localized Alopecia Areata Phase 4
Completed NCT02018042 - An Open-Label Single-Arm Clinical Trial to Evaluate The Efficacy of Abatacept in Moderate to Severe Patch Type Alopecia Areata Phase 2
Terminated NCT01898806 - Intralesional Steroids in the Treatment of Alopecia Areata Phase 4
Recruiting NCT04011748 - Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Phase 2
Terminated NCT04517864 - PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA Phase 2
Not yet recruiting NCT05803070 - Topical Cetirizine in Treatment of Localized Alopecia Areata
Not yet recruiting NCT05496426 - A Study of KL130008 in Adults With Severe Alopecia Areata Phase 2
Completed NCT04147845 - Transepidermal Delivery of Triamcinolone Acetonide or Platelet Rich Plasma Using Either Fractional Carbon Dioxide Laser or Microneedling in Treatment of Alopecia Areata N/A
Terminated NCT03325296 - Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata. Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Enrolling by invitation NCT05745389 - CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Not yet recruiting NCT06087796 - Topical Pentoxifylline; Metformin Versus Betamethasone in the Treatment of Alopecia Areata. Phase 1
Withdrawn NCT03532958 - Phase 2 Trial of BNZ-1 in Patients With Moderate to Severe Alopecia Areata Phase 2
Recruiting NCT02604888 - Efficacy Study of a Cosmetic Lotion in the Treatment of Alopecia Areata in Males and Females N/A
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Completed NCT00408798 - Treatment of Alopecia Areata of the Scalp With Intradermal Injections of Botulinum Toxin N/A

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