What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata, particularly JAK inhibitors like Baricitinib, have been associated with several side effects. For Baricitinib, these include headache, increased blood creatine phosphokinase levels, decreased neutrophil count, and nasopharyngitis. Other JAK inhibitors, such as tofacitinib, have shown side effects like infection, increased blood creatine phosphokinase, and contact dermatitis. Additionally, treatments like cyclosporine and methotrexate, which are sometimes used for refractory cases, can cause serious adverse effects such as liver enzyme elevation, pancreatitis, bone marrow suppression, and the need for close laboratory monitoring due to potential toxicities.

What prior FDA approvals exist?

As of now, the FDA has not approved any specific Janus kinase (JAK) inhibitors for the treatment of Alopecia Areata. However, several JAK inhibitors, including Baricitinib, are being studied for their efficacy and safety in treating this condition. Other JAK inhibitors like Tofacitinib and Ruxolitinib have shown promise in clinical studies and case series, but they are not yet FDA-approved for Alopecia Areata. These treatments are part of ongoing research to find effective therapies for this autoimmune disorder.

What other types of research exist?

Promising alternatives to Baricitinib for Alopecia Areata include: 1) Tofacitinib: Shown to improve hair regrowth in both adults and children with Alopecia Areata, Alopecia Totalis, and Alopecia Universalis. 2) Ruxolitinib: Demonstrated partial hair regrowth in patients with Alopecia Universalis. 3) Dupilumab: Showed potential benefits in a phase 2 trial, with some patients achieving significant improvement in the SALT score. Further studies are needed to confirm its efficacy.

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Janus Kinase (JAK) Inhibitor

Baricitinib for Alopecia Areata (BRAVE-AA2 Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline.

No spontaneous improvement over the past 6 months.

Must not have

Primarily "diffuse" type of AA.

Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Pivotal Trial

Summary

This trial is testing baricitinib to see if it is safe and effective for adults with severe hair loss due to alopecia areata. The drug works by calming the immune system to prevent it from attacking hair follicles. Baricitinib was approved by the FDA for treating severe alopecia areata.

Who is the study for?

Adults with severe or very severe alopecia areata (AA) for less than 8 years, or those with regrowth in the past 8 years, can join. They must be aged between 18-60 for males and up to 70 for females, not pregnant or breastfeeding, and have had no hair improvement in the last six months.

What is being tested?

The study is testing if Baricitinib is effective and safe compared to a placebo in adults with severe AA. Participants will either receive Baricitinib or a placebo without knowing which one they're getting.

What are the potential side effects?

Baricitinib may cause side effects such as infections, blood clots, cholesterol changes, liver enzyme elevations, and possibly others. The exact side effects experienced by participants will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had severe scalp hair loss for over 6 months.

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My condition has not gotten better on its own in the last 6 months.

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I am a male aged 18-60 or a female aged 18-70.

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I am a man or a woman not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is primarily the 'diffuse' type of astrocytoma.

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I took a JAK inhibitor for over 12 weeks without seeing hair growth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20

Secondary study objectives

Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36

Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36

Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score

+10 more

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358

Nasopharyngitis

Pharyngitis

Urinary tract infection

Bronchitis

Back pain

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Adalimumab Treatment B

Placebo Follow-up

Baricitinib Follow-up

BaricitinibTreatment B

Placebo Treatment B

Adalimumab Follow-up

Baricitinib Treatment A

Adalimumab Treatment A

Placebo Treatment A

Rescue

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: 4 mg Baricitinib Maximum Extended Enrollment (MEE)Experimental Treatment2 Interventions

Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.

Group II: 4 Milligram (mg) BaricitinibExperimental Treatment2 Interventions

Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.

Group III: 2 mg Baricitinib MEEExperimental Treatment1 Intervention

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.

Group IV: 2 mg BaricitinibExperimental Treatment2 Interventions

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.

Group V: Placebo MEEPlacebo Group1 Intervention

Participants received two placebo tablets administered orally QD to maintain the blind.

Group VI: PlaceboPlacebo Group1 Intervention

Participants received two placebo tablets administered orally QD to maintain the blind.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Baricitinib

2017

Completed Phase 3

~9510

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alopecia Areata include JAK inhibitors like Baricitinib, which work by interfering with the JAK-STAT signaling pathways that are involved in the immune response. By inhibiting these pathways, JAK inhibitors can reduce inflammation and autoimmunity, which are key factors in Alopecia Areata. Other treatments include corticosteroids, which suppress the immune system to reduce inflammation, and immunosuppressants like methotrexate and cyclosporine, which also modulate the immune response. Understanding these mechanisms is crucial for patients as it highlights the importance of targeting the immune system to manage and potentially reverse hair loss in Alopecia Areata.

Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?