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

NCT06797310 | Not Yet Recruiting Phase 2

• 1 other identifier: 202401193MIPB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Acute alopecia areata; active hair shedding

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

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.

Drug: Baricitinib

Interventions

Baricitinib DRUG

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.

Baricitinib Treatment for Acute Alopecia Areata with Active Hair Shedding

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Alopecia Areata

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sung-Lan Lin, PhD

CONTACT

886+972651773; drsjlin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sung-Jan Lin

Model Details: Prospective open label study

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: January 23, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)