Alopecia AreataNCT06279221
Litfulo Capsules Special Investigation
An observational study of Alopecia Areata, run by Pfizer at 1 site in Japan.
Trial summary
The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- LITFULO
- How many people
- 664 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2024to 18 Jan 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with alopecia areata who received LITFULO
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients with alopecia areata who start receiving this drug for the first time after the contract date of this study
- Patients who have not participated in a clinical trial (clinical study) of this drug
Who cannot join
- Patients meeting any of the following criteria will not be included in the study:
- Patients previously enrolled in this study
- Patients with a history of treatment with this drug (including investigational product)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LITFULO® CAPSULES SPECIAL INVESTIGATION
The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.
Read the detailed description
This study is an open-label, multi-center, one arm prospective observational cohort study of patients receiving this drug. The investigators complete the CRF based on the information extracted from the medical record created in daily medical practice.
- Conditions
- Alopecia Areata
- Being tested
- LITFULO
- 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
as provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Japanese participants with alopecia areata | Japanese participants with alopecia areata Receives: Drug: LITFULO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with adverse events (AEs)
Measured: Baseline through year 3
Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less]
The percentage of patients who achieved SALT ≤ 20 (absolute SALT score of ≤ 20) will be calculated at baseline (including the first day of treatment) and each evaluation time point after the start of treatment with this drug.
Measured: Baseline, evaluation at Week 12, Week 24 , Week 48, Week 78 , Week 104 , Week 130 , and Week 156 after the start of administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion18 Jan 2030 (estimated)
- Study completion18 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 664 participants (actual)
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
- NCT06279221
- Sponsor's protocol ID
- B7981055
- Other IDs
- NCT06279221
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LITFULO® CAPSULES SPECIAL INVESTIGATION
- ClinicalTrials.gov ID
- NCT06279221
- Acronym / sponsor ID
- B7981055
- Conditions
- Alopecia Areata
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 664 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 18 Jan 2030 (estimated)
- Study completion
- 18 Jan 2030 (estimated)
- First posted
- 28 Feb 2024 (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 objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.
Detailed description
This study is an open-label, multi-center, one arm prospective observational cohort study of patients receiving this drug. The investigators complete the CRF based on the information extracted from the medical record created in daily medical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Japanese participants with alopecia areata | – | Drug: LITFULOJapanese participants with alopecia areata |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with alopecia areata who received LITFULO
Key inclusion criteria (3 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients with alopecia areata who start receiving this drug for the first time after the contract date of this study
- Patients who have not participated in a clinical trial (clinical study) of this drug
Key exclusion criteria (3 listed)
- Patients previously enrolled in this study
- Patients with a history of treatment with this drug (including investigational product)
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 |
|---|---|---|
| LITFULOas provided in real world practice | Drug | Japanese participants with alopecia areata |
Primary outcome
Proportion of participants with adverse events (AEs)
Time frame: Baseline through year 3
Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less]
Time frame: Baseline, evaluation at Week 12, Week 24 , Week 48, Week 78 , Week 104 , Week 130 , and Week 156 after the start of administration.
The percentage of patients who achieved SALT ≤ 20 (absolute SALT score of ≤ 20) will be calculated at baseline (including the first day of treatment) and each evaluation time point after the start of treatment with this drug.
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 27 Aug 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. This study is not recruiting at the moment.
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 Alopecia Areata, run by Pfizer at 1 site in Japan.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 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 Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with adverse events (AEs) (time frame: Baseline through year 3). The study lists 2 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 27 Aug 2026.