NCT06797310

Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	Baricitinib	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.

Timeline

• Start date: 2025-01-23
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-01-28
• Last updated: 2025-01-28

Locations

1 site across 1 country: Taiwan