Litfulo capsule for people with severe alopecia areata in routine care
Korean Post Marketing Surveillance for Litfulo Capsule
People aged 12 and older with severe alopecia areata who start Litfulo capsules will be followed in routine clinics to see if the medicine is safe and what effects it has.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07152119 on ClinicalTrials.gov |
What this trial studies
This is a post‑marketing observational study that follows patients prescribed Litfulo (ritlecitinib tosylate) during routine clinical care to collect safety and outcome data. No experimental procedures are required beyond standard treatment; clinicians will record adverse events, serious adverse events, adverse events of special interest (including serious infections, opportunistic infections, herpes zoster, and malignancy), and any unexpected reactions. Eligible participants are adolescents (12 years and older) and adults with severe alopecia areata who are starting Litfulo per its approved indication and who provide informed consent. Data will be collected at the Pfizer clinical site in Seoul and analyzed to identify real‑world safety signals and treatment patterns.
Who should consider this trial
Good fit: Ideal candidates are adolescents (12 years and older) and adults with severe alopecia areata whose clinician has decided to start Litfulo and who provide informed consent.
Not a fit: Patients who are not starting Litfulo, who are younger than 12, or who have contraindications to the medicine are unlikely to receive benefit from joining this observational safety study.
Why it matters
Potential benefit: If successful, the study could improve understanding of Litfulo’s real‑world safety profile and help clinicians make better-informed treatment choices.
How similar studies have performed: Randomized trials of ritlecitinib and other JAK inhibitors have shown clinical benefit in alopecia areata, but this post‑marketing observational study focuses on collecting real‑world safety data.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Seoul
- Pfizer, Inc — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.