Alopecia AreataPhase 2MQ7422NCT06797310
Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study
A Phase 2 study testing Baricitinib in people with Alopecia Areata, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Alopecia areata (AA) in the acute phase with active hair shedding causes significant psychological distress, prompting the need for effective treatment. While baricitinib has shown efficacy in chronic AA with extensive hair loss (SALT ≥ 50), its impact on acute AA remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Baricitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jan 2025to 31 Dec 2026
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be between 18 and 65 years of age (inclusive) at the time of enrollment. Subjects are eligible if they are male or nonpregnant, nonbreastfeeding female patients.
- Active AA is defined as 30% or more of scalp surface area with active shedding via pull test
- Current AA episode onset within 3 months
Who cannot join
- Causes of acute hair shedding other than AA;
- AA, in which the activity and/or onset time cannot be accurately determined;
- Other medical concomitant conditions that require the use of systemic corticosteroids or immunosuppressants within 8 weeks of the baseline visit;
- Intralesional steroid injection for AA within 4 weeks;
- Previous treatment with oral JAKi with an inadequate response;
- Have evidence of active TB or latent TB without completing at least 4 weeks of appropriate treatment;
Show all 19Show fewer
- Have any of the following specific abnormalities on screening laboratory tests: ANC <1,000 cells/mm³; ALC <500 cells/mm³; Hb levels <8 g/dL, platelets <100,000 cells/μL; AST or ALT ≥2 × ULN; ALP ≥2 × ULN; TBL ≥1.5 × ULN; eGFR <60 mL/min/1.73m2
- Have an active, serious infection, including localized infection;
- Have had symptomatic herpes zoster infection within 12 weeks before randomization. Have a history of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement);
- Have a positive test for hepatitis B virus (HBV) infection, defined as positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) and positive HBV deoxyribonucleic acid (DNA).
- Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive);
- Have evidence of HIV infection and/or positive HIV antibodies;
- Have been exposed to a live vaccine within 12 weeks or are expected to need/receive a live vaccine during the course of the study (except herpes zoster vaccination);
- Have a history of chronic alcohol abuse, intravenous drug abuse, or other illicit drug abuse within the 2 years before study entry;
- Have a history of cancer, or have an active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years (except fully treated NMSC and SCCis of the cervix). Have a history of lymphoproliferative disease; have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly;
- Have experienced any of the following within 12 weeks of screening: VTE (DVT/pulmonary embolism [PE]), myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage III/IV heart failure;
- Have had any major surgery within 8 weeks before screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the patient;
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that in the opinion of the investigator, could constitute an unacceptable risk when taking the investigational product or interfere with the interpretation of data;
- Any other condition in the opinion of the investigator which would interfere with the study assessments or procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Sung-Jan Lin, PhD, 886+972651773, drsjlin@ntu.edu.tw
About this study
Alopecia areata (AA) in the acute phase with active hair shedding causes significant psychological distress, prompting the need for effective treatment. While baricitinib has shown efficacy in chronic AA with extensive hair loss (SALT ≥ 50), its impact on acute AA remains unclear. Clinical observations suggest that baricitinib can reduce or halt hair shedding within 4-6 weeks, offering a faster response than conventional treatments like systemic corticosteroids. This 16-week, single-center, open-label study aims to evaluate the effectiveness of baricitinib in 30 patients with acute AA and active shedding. Participants will receive 4 mg daily for 16 weeks, with responders tapering to 2 mg for an additional 16 weeks. Follow-up visits will occur at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52. The primary endpoint is achieving an iSARS-AA score of 20 or less at week 16. This study will provide real-world insights into baricitinib's role in managing acute AA.
Read the detailed description
Alopecia areata (AA) patients in the acute phase with active hair shedding experience significant psychological distress and an urgent need for effective treatment. The autoimmune nature of AA, driven by T-cell-mediated attacks on anagen hair follicles, leads to progressive hair loss. While baricitinib has been shown to promote hair regrowth in chronic AA with extensive hair loss (SALT ≥ 50), its efficacy in acute AA with active shedding has not been evaluated in BRAVE-AA1/2 trials. Clinical observations suggest that baricitinib can reduce or halt hair shedding within 4-6 weeks, offering a faster response compared to conventional treatments such as systemic corticosteroids, which often take longer or fail to achieve this outcome. This study aims to evaluate the effectiveness of baricitinib in patients with acute AA experiencing active shedding in a real-world setting. A 16-week, single-center, open-label, prospective trial will be conducted, enrolling 30 patients with active AA and progressive hair loss. Participants will receive 4 mg of baricitinib daily for 16 weeks, with responders tapering to 2 mg for an additional 16 weeks before discontinuation. Scheduled follow-up visits will be conducted at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52. The primary endpoint is achieving an iSARS-AA score of 20 or less at week 16. Findings from this study will provide valuable insights into the real-world effectiveness of baricitinib in managing acute AA with active hair shedding.
- Conditions
- Alopecia Areata
- Being tested
- Baricitinib
- Keywords
- Acute alopecia areata, active hair shedding
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
This study evaluates the use of baricitinib 4 mg once daily for 16 weeks in patients with acute alopecia areata (AA) experiencing active hair shedding. Unlike prior studies focusing on chronic AA with extensive hair loss (SALT ≥ 50), this intervention targets the acute phase, aiming to halt shedding within 4-6 weeks-faster than conventional treatments like corticosteroids. Patients meeting the primary endpoint (iSARS-AA ≤ 20 at week 16) will taper to 2 mg daily for an additional 16 weeks. Scheduled follow-ups at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52 ensure comprehensive monitoring, distinguishing this study from others with shorter follow-ups or less frequent assessments.
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib Treatment for Acute Alopecia Areata with Active Hair Shedding | Experimental | This study arm evaluates the effectiveness of baricitinib in patients with acute alopecia areata (AA) experiencing active hair shedding. Participants will receive baricitinib at a dose of 4 mg once daily for 16 weeks. Patients who achieve the primary endpoint, defined as an iSARS-AA score of 20 or less at week 16, will taper to 2 mg once daily for an additional 16 weeks before discontinuation. The intervention aims to rapidly halt hair shedding and promote regrowth, with follow-up visits scheduled at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52 to monitor treatment response and potential relapse. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the iSARS-AA (International Alopecia Areata Research Society - Alopecia Areata Severity Score)
The primary outcome measure is the iSARS-AA (International Alopecia Areata Research Society - Alopecia Areata Severity Score), with the goal of achieving a score of 20 or less at week 16. This outcome will assess the reduction in alopecia severity and the effectiveness of baricitinib in halting active hair shedding in patients with acute alopecia areata.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start23 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (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 National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective open label study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797310
- Sponsor's protocol ID
- 202401193MIPB
- Acronym
- MQ7422
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study
- ClinicalTrials.gov ID
- NCT06797310
- Acronym / sponsor ID
- MQ7422 / 202401193MIPB
- Conditions
- Alopecia Areata
- Keywords
- Acute alopecia areata, active hair shedding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 23 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jan 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.
Alopecia areata (AA) in the acute phase with active hair shedding causes significant psychological distress, prompting the need for effective treatment. While baricitinib has shown efficacy in chronic AA with extensive hair loss (SALT ≥ 50), its impact on acute AA remains unclear. Clinical observations suggest that baricitinib can reduce or halt hair shedding within 4-6 weeks, offering a faster response than conventional treatments like systemic corticosteroids. This 16-week, single-center, open-label study aims to evaluate the effectiveness of baricitinib in 30 patients with acute AA and active shedding. Participants will receive 4 mg daily for 16 weeks, with responders tapering to 2 mg for an additional 16 weeks. Follow-up visits will occur at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52. The primary endpoint is achieving an iSARS-AA score of 20 or less at week 16. This study will provide real-world insights into baricitinib's role in managing acute AA.
Detailed description
Alopecia areata (AA) patients in the acute phase with active hair shedding experience significant psychological distress and an urgent need for effective treatment. The autoimmune nature of AA, driven by T-cell-mediated attacks on anagen hair follicles, leads to progressive hair loss. While baricitinib has been shown to promote hair regrowth in chronic AA with extensive hair loss (SALT ≥ 50), its efficacy in acute AA with active shedding has not been evaluated in BRAVE-AA1/2 trials. Clinical observations suggest that baricitinib can reduce or halt hair shedding within 4-6 weeks, offering a faster response compared to conventional treatments such as systemic corticosteroids, which often take longer or fail to achieve this outcome. This study aims to evaluate the effectiveness of baricitinib in patients with acute AA experiencing active shedding in a real-world setting. A 16-week, single-center, open-label, prospective trial will be conducted, enrolling 30 patients with active AA and progressive hair loss. Participants will receive 4 mg of baricitinib daily for 16 weeks, with responders tapering to 2 mg for an additional 16 weeks before discontinuation. Scheduled follow-up visits will be conducted at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52. The primary endpoint is achieving an iSARS-AA score of 20 or less at week 16. Findings from this study will provide valuable insights into the real-world effectiveness of baricitinib in managing acute AA with active hair shedding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective open label study
| Arm | Type | Receives |
|---|---|---|
| Baricitinib Treatment for Acute Alopecia Areata with Active Hair Shedding | Experimental | Drug: BaricitinibThis study arm evaluates the effectiveness of baricitinib in patients with acute alopecia areata (AA) experiencing active hair shedding. Participants will receive baricitinib at a dose of 4 mg once daily for 16 weeks. Patients who achieve the primary endpoint, defined as an iSARS-AA score of 20 or less at week 16, will taper to 2 mg once daily for an additional 16 weeks before discontinuation. The intervention aims to rapidly halt hair shedding and promote regrowth, with follow-up visits scheduled at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52 to monitor treatment response and potential relapse. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be between 18 and 65 years of age (inclusive) at the time of enrollment. Subjects are eligible if they are male or nonpregnant, nonbreastfeeding female patients.
- Active AA is defined as 30% or more of scalp surface area with active shedding via pull test
- Current AA episode onset within 3 months
Key exclusion criteria (19 listed)
- Causes of acute hair shedding other than AA;
- AA, in which the activity and/or onset time cannot be accurately determined;
- Other medical concomitant conditions that require the use of systemic corticosteroids or immunosuppressants within 8 weeks of the baseline visit;
- Intralesional steroid injection for AA within 4 weeks;
- Previous treatment with oral JAKi with an inadequate response;
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 |
|---|---|---|
| BaricitinibThis study evaluates the use of baricitinib 4 mg once daily for 16 weeks in patients with acute alopecia areata (AA) experiencing active hair shedding. Unlike prior studies focusing on chronic AA with extensive hair loss (SALT ≥ 50), this intervention targets the acute phase, aiming to halt shedding within 4-6 weeks-faster than conventional treatments like corticosteroids. Patients meeting the primary endpoint (iSARS-AA ≤ 20 at week 16) will taper to 2 mg daily for an additional 16 weeks. Scheduled follow-ups at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52 ensure comprehensive monitoring, distinguishing this study from others with shorter follow-ups or less frequent assessments. | Drug | Baricitinib Treatment for Acute Alopecia Areata with Active Hair Shedding |
Primary outcome
The primary outcome measure is the iSARS-AA (International Alopecia Areata Research Society - Alopecia Areata Severity Score)
Time frame: From enrollment to the end of treatment at 8 weeks
The primary outcome measure is the iSARS-AA (International Alopecia Areata Research Society - Alopecia Areata Severity Score), with the goal of achieving a score of 20 or less at week 16. This outcome will assess the reduction in alopecia severity and the effectiveness of baricitinib in halting active hair shedding in patients with acute alopecia areata.
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib in people with Alopecia Areata, run by National Taiwan University Hospital at 1 site in Taiwan.
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 19 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: opening soon, as of the sponsor's last update on 28 Jan 2025. 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sung-Lan Lin, PhD (886+972651773, drsjlin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the iSARS-AA (International Alopecia Areata Research Society - Alopecia Areata Severity Score) (time frame: From enrollment to the end of treatment at 8 weeks). 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 28 Jan 2025.