Clinical trial NCT06797310: Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: Acute alopecia areata
active hair shedding
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2025-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective open label study
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Active AA is defined as 30% or more of scalp surface area with active shedding via pull test
3. Current AA episode onset within 3 months

Exclusion Criteria:

1. Causes of acute hair shedding other than AA;
2. AA, in which the activity and/or onset time cannot be accurately determined;
3. Other medical concomitant conditions that require the use of systemic corticosteroids or immunosuppressants within 8 weeks of the baseline visit;
4. Intralesional steroid injection for AA within 4 weeks;
5. Previous treatment with oral JAKi with an inadequate response;
6. Have evidence of active TB or latent TB without completing at least 4 weeks of appropriate treatment;
7. 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
8. Have an active, serious infection, including localized infection;
9. 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);
10. 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).
11. Have hepatitis C virus (HCV) infection (hepatitis C antibody-positive and HCV ribonucleic acid \[RNA\]-positive);
12. Have evidence of HIV infection and/or positive HIV antibodies;
13. 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);
14. Have a history of chronic alcohol abuse, intravenous drug abuse, or other illicit drug abuse within the 2 years before study entry;
15. 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;
16. 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;
17. 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;
18. 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;
19. Any other condition in the opinion of the investigator which would interfere with the study assessments or procedure.

Primary outcomes:
measure: The primary outcome measure is the iSARS-AA (International Alopecia Areata Research Society - Alopecia Areata Severity Score)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: