Severe Alopecia AreataNCT07152119
A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.
An observational study of Severe Alopecia Areata, run by Pfizer at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Severe Alopecia Areata
- What is being tested?
- Litfulo
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Aug 2025to 23 Mar 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe alopecia areata
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: KOREAN POST MARKETING SURVEILLANCE FOR LITFULO CAPSULE
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.
Read the detailed 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
- Conditions
- Severe Alopecia Areata
- Being tested
- Litfulo
- Keywords
- Litfulo, Litfulo capsule, Ritlecitinib tosylate
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LitfuloDrug
Also called Ritlecitinib tosylate (ATC code: L04AF08)
as provided in real world practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe alopecia areata. | Determined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product. Receives: Drug: Litfulo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and proportion of AEs/ADRs
Measured: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of unexpected AEs/ADRs
Measured: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of SAEs/SADRs
Measured: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of AESI
Measured: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Secondary outcomes (4)
Proportion of patients achieving Severity of Alopecia Tool (SALT) ≤20 score at Weeks 24 and 48
Measured: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48
Measured: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving 50% or above improvement in SALT score from baseline (SALT 50) at Weeks 24 and 48
Measured: 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
Measured: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start27 Aug 2025
- Primary completion23 Mar 2030 (estimated)
- Study completion23 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Alopecia AreataStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152119
- Sponsor's protocol ID
- B7981084
- Status last verified
- May 2026
- First submitted
- 25 Aug 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.