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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KOREAN POST MARKETING SURVEILLANCE FOR LITFULO CAPSULE
- ClinicalTrials.gov ID
- NCT07152119
- Acronym / sponsor ID
- B7981084
- Conditions
- Severe Alopecia Areata
- Keywords
- Litfulo, Litfulo capsule, Ritlecitinib tosylate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 23 Mar 2030 (estimated)
- Study completion
- 23 Mar 2030 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe alopecia areata. | – | Drug: LitfuloDetermined to start treatment with Litfulo Capsule according to the approved indications of the medicinal product. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe alopecia areata
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LitfuloAlso: Ritlecitinib tosylate (ATC code: L04AF08)as provided in real world practice. | Drug | Patients with severe alopecia areata. |
Primary outcome
Frequency and proportion of AEs/ADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of unexpected AEs/ADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of SAEs/SADRs
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Frequency and proportion of AESI
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
4 secondary outcomes
Proportion of patients achieving Severity of Alopecia Tool (SALT) ≤20 score at Weeks 24 and 48
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Proportion of patients achieving SALT ≤10 score at Weeks 24 and 48
Time frame: 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
Time frame: 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
Time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Alopecia Areata, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and proportion of AEs/ADRs (time frame: 24 weeks (Regular surveillance), 48 weeks (Long-term surveillance)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.