Baricitinib for Alopecia

Overseen By Ralee' Bunt, MSPH

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Alabama at Birmingham

Must not be taking: Finasteride, Pioglitazone, Hydroxychloroquine, others

Disqualifiers: Pregnancy, Breastfeeding, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 36 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Baricitinib, a medication, to evaluate its safety and effectiveness in treating frontal fibrosing alopecia (FFA), a condition causing hair loss at the front of the scalp. All participants will take the same daily dose of Baricitinib for 36 weeks. Post-menopausal women who have noticed signs like hairline recession and eyebrow loss due to FFA may be eligible to join. As a Phase 4 trial, Baricitinib is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic treatments for FFA, like finasteride or immunosuppressants, at least 4 weeks before starting. If you're on dutasteride, you need to stop 6 months before. Other medications are not specified, so check with the trial team.

What is the safety track record for Baricitinib?

Research has shown that Baricitinib is generally well-tolerated by people with severe alopecia areata, a condition that causes hair loss. Studies have found that most side effects from the treatment are mild to moderate, while serious side effects are uncommon, occurring at a rate of 2.6 per year.

The FDA has already approved Baricitinib for other uses, indicating its safety for wider use. This trial is in a later stage, meaning a substantial amount of safety information is already available. The trial aims to confirm its safety specifically for frontal fibrosing alopecia, a type of hair loss at the front and sides of the scalp. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Baricitinib is unique because it offers a new approach to treating alopecia by targeting specific pathways in the immune system. Unlike traditional treatments like corticosteroids or topical immunotherapy, which often have varying effectiveness and can come with significant side effects, Baricitinib is a Janus kinase (JAK) inhibitor. This means it works by interfering with the enzymes that contribute to inflammation and immune responses that lead to hair loss. Researchers are excited about Baricitinib because it has the potential to provide a more targeted and effective treatment with a consistent daily oral dose, potentially leading to better outcomes for patients with alopecia.

What is the effectiveness track record for Baricitinib in treating frontal fibrosing alopecia?

Research has shown that Baricitinib can effectively treat severe alopecia areata, a condition that causes hair loss. In one study, 63% of patients experienced significant hair regrowth after 48 weeks. Another study found that Baricitinib outperformed a placebo for hair regrowth after 36 weeks. Some patients maintained or improved their hair regrowth over two years. This treatment offers hope for those struggling with hair loss. ^{3 4 5 6 7}

Who Is on the Research Team?

Boni Elewski, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals with frontal fibrosing alopecia (FFA), a type of hair loss affecting the front of the scalp. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of FFA.

Inclusion Criteria

I am experiencing hair loss at the front of my scalp.

I have lost my eyebrows.

I agree to avoid live vaccines during the study, except for the herpes zoster vaccine.

Exclusion Criteria

Subject is pregnant or breastfeeding

Immunocompromised and with risk factors concerning to investigator for study participation

I have not had procedures like facelifts or micro-blading that could affect my scalp or eyebrows.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4mg of Baricitinib daily for 36 weeks

36 weeks

Visits at baseline, week 12, 24, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Baricitinib

Trial Overview

The study is testing Baricitinib, a medication taken as a 4 mg oral tablet, to see if it's safe and effective in treating FFA. The main goal is to determine whether this drug can help manage symptoms or halt progression of hair loss in affected individuals.

How Is the Trial Designed?

Group I: Baricitinib Experimental Treatment 1 Intervention

All patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks.

Baricitinib is already approved in United States, European Union for the following indications:

Approved in United States as Olumiant for:

• Rheumatoid arthritis
• Severe alopecia areata
• COVID-19

Approved in European Union as Olumiant for:

• Rheumatoid arthritis
• Severe alopecia areata
• COVID-19

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

Baricitinib (Olumiant®) has been shown to significantly improve scalp coverage in patients with alopecia areata, with a higher percentage achieving at least 80% coverage after 36 weeks of treatment compared to placebo in two phase-3 trials.

While generally effective, baricitinib can cause side effects such as acne and urinary tract infections, and it is important to follow the recommended dosage of 2 mg or 4 mg daily based on hair loss severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olumiant® (Baricitinib)-A Newly Approved Janus Kinase Inhibitor for the Treatment of Alopecia Areata. Gupta, AK., Wang, T., Vincent, K., et al.[2022]

Baricitinib, a JAK1/JAK2 inhibitor, has been shown to have a favorable safety profile in treating severe alopecia areata, with data collected from 1303 patients over a median of 532 days, indicating no deaths and a low incidence of serious infections.

Common treatment-emergent adverse events included upper respiratory infections and acne, with some differences noted compared to its use in atopic dermatitis, suggesting that the safety profile may vary based on the specific condition being treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. King, B., Mostaghimi, A., Shimomura, Y., et al.[2023]

In the BRAVE-AA1 and BRAVE-AA2 phase III trials, 69% of patients treated with baricitinib 4 mg and 51% with 2 mg achieved at least a 30% improvement in hair regrowth (SALT30) by week 52, indicating the efficacy of baricitinib in treating severe alopecia areata.

The study identified three responder subgroups based on the timing of achieving SALT30: early (by week 12), gradual (between weeks 12-36), and late (after week 36), with early responders showing the best outcomes, particularly among patients with less severe baseline alopecia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When to expect scalp hair regrowth during treatment of severe alopecia areata with baricitinib: insights from trajectories analyses of patients enrolled in two phase III trials. King, B., Shapiro, J., Ohyama, M., et al.[2023]

In a study involving 855 adults with severe alopecia areata, treatment with baricitinib (2 mg and 4 mg) showed continued improvement in scalp hair growth up to week 52, indicating its long-term efficacy.

Patients with a baseline Severity of Alopecia Tool (SALT) score of 50-94 responded better to baricitinib compared to those with scores of 95-100, and the higher 4 mg dose resulted in faster and greater response rates than the 2 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Baricitinib in Patients with Various Degrees of Alopecia Areata Severity: Post-Hoc Analysis from BRAVE AA1 and BRAVE AA2. Taylor, S., Korman, NJ., Tsai, TF., et al.[2023]

Baricitinib, a JAK inhibitor, is the first approved treatment for severe alopecia areata, showing significant hair regrowth in scalp, eyebrows, and eyelashes over 36 weeks in two phase 3 clinical trials.

The drug was generally well tolerated, with common side effects including infections and headaches, indicating it is a promising option for patients suffering from this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib: A Review in Severe Alopecia Areata. Fung, S., Shirley, M.[2023]

In a pooled analysis of two phase 3 trials involving 1200 adults with severe alopecia areata, increasing the dose of baricitinib from 2 mg to 4 mg led to significant improvements in hair regrowth, with 25.9% of previously non-responding patients achieving a SALT score of 20 or lower by week 76.

Clinician-reported outcomes for eyebrow and eyelash hair loss also improved, with response rates increasing from 19.3% to 37.9% for eyebrows and from 24.1% to 40.9% for eyelashes, demonstrating the efficacy of uptitration in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials. Ko, JM., Mayo, TT., Bergfeld, WF., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40985491/

Effectiveness and safety of baricitinib in severe alopecia ...

Key findings: After 48 weeks, 63% of patients had major scalp hair regrowth (SALT ≤20), and over 75% had moderate regrowth (SALT ≤30).

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2110343

Two Phase 3 Trials of Baricitinib for Alopecia Areata

In two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38391212/

Baricitinib: Long-term efficacy & safety in alopecia areata

Baricitinib demonstrated a high level of maintenance of efficacy over 104 weeks in patients with severe AA. Efficacy increased in Week-52 mixed responders.

4.

ajmc.com

ajmc.com/view/baricitinib-leads-to-significant-hair-regrowth-in-adolescents-with-severe-alopecia-areata

Baricitinib Leads to Significant Hair Regrowth in ...

Baricitinib showed significant hair regrowth in adolescents with severe alopecia areata, with 71% achieving successful scalp regrowth at 52 ...

5.

olumiant.lilly.com

olumiant.lilly.com/alopecia-areata/olumiant-results

Olumiant® Results in Alopecia Areata

Olumiant results in alopecia areata. In clinical studies, some adults with severe alopecia areata taking Olumiant achieved 80% scalp hair coverage at 36 ...

6.

naaf.org

naaf.org/news/lilly-shares-52-week-results-of-baricitinib-olumiant-for-treatment-of-severe-alopecia-areata-in-adolescents-demonstrating-near-complete-hair-regrowth/

Lilly shares 52-week results of baricitinib (Olumiant®) for ...

The data showed that 71% of adolescents with severe AA treated with baricitinib 4 mg, “achieved successful scalp hair regrowth at one year, with ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40214720/

Safety of Baricitinib in Adults with Severe Alopecia Areata ...

Most treatment-emergent adverse events were mild to moderate in severity. Incidence rates of serious adverse events (IR = 2.6) and treatment ...