A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.

Pfizer

Status

Enrolling

Conditions

Severe Alopecia Areata

Treatments

Drug: Litfulo

Study type

Observational

Funder types

Industry

Identifiers

NCT07152119

B7981084

Details and patient eligibility

About

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.

Full description

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)
- Serious Infections, defined as any infection (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy or hospitalization for treatment or meeting other criteria that require the infection to be classified as serious adverse event
- Opportunistic infections and Herpes Zoster
- Malignancy

Enrollment

3,000 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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