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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.
To evaluate the safety of Litfulo Capsule after marketing, with regard to the following clauses in routine clinical practice.
Adverse Events (AEs)/ Adverse Drug Reactions (ADRs)
Unexpected Adverse Events (AEs)/ADRs that have not been reflected in the approved drug label
Serious Adverse Events (SAEs)/Serious Adverse Drug Reaction (SADRs)
Adverse Event of Special Interest(AESI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe alopecia areata. | Determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Litfulo | Drug | as provided in real world practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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
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Patients with severe alopecia areata
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Recruiting | Seoul | South Korea |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
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| 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) |
| D017437 |
| Skin and Connective Tissue Diseases |