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Janus Kinase (JAK) Inhibitor

Baricitinib for Alopecia Areata (BRAVE-AA1 Trial)

Phase 2 & 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
Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
Have severe or very severe AA, as determined by all of the following:
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 36

Summary

This trial will help determine if baricitinib is an effective treatment for severe or very severe alopecia areata, and what the best dosage is.

Who is the study for?
This trial is for adults with severe or very severe alopecia areata (AA) who haven't seen hair regrowth in the past 6 months. Participants should have had AA for more than 6 months but less than 8 years, and lost over half their scalp hair. Women must not be pregnant or breastfeeding. People with diffuse AA, other alopecia types, conditions affecting study results, or inadequate response to oral JAK inhibitors are excluded.
What is being tested?
The trial is testing two doses of Baricitinib against a placebo to see how well they work and how safe they are for treating severe AA. Some participants will join an open-label part where everyone gets Baricitinib without being compared to a placebo.
What are the potential side effects?
Baricitinib may cause side effects like infections, blood clots, changes in blood tests that measure liver health, cholesterol levels increase, and allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a male aged 18-60 or a female aged 18-70.
Select...
My condition is classified as severe or very severe AA.
Select...
My condition has not gotten better on its own in the last 6 months.
Select...
I have had significant hair loss for over 6 months.
Select...
I have had severe scalp hair loss for over 6 months.
Select...
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:
Select...
My alopecia areata is mainly of the diffuse type.
Select...
I took a JAK inhibitor for over 12 weeks without significant hair growth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36 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
Mean Change From Baseline in HADS Depression Score
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score
Percent Change from Baseline in SALT Score
+6 more

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358
5%
Nasopharyngitis
3%
Pharyngitis
2%
Urinary tract infection
2%
Bronchitis
1%
Back pain
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
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

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label Addenda Baricitinib High DoseExperimental Treatment1 Intervention
Baricitinib will be administered orally during the open-label addenda.
Group II: Baricitinib Low DoseExperimental Treatment2 Interventions
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Group III: Baricitinib High DoseExperimental Treatment2 Interventions
Baricitinib administered orally. Placebo administered orally to maintain the blind.
Group IV: PlaceboPlacebo Group1 Intervention
Participants administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,228,198 Total Patients Enrolled
3 Trials studying Alopecia Areata
1,156 Patients Enrolled for Alopecia Areata
Incyte CorporationIndustry Sponsor
391 Previous Clinical Trials
63,011 Total Patients Enrolled
2 Trials studying Alopecia Areata
636 Patients Enrolled for Alopecia Areata
Study DirectorEli Lilly and Company
1,386 Previous Clinical Trials
425,823 Total Patients Enrolled
1 Trials studying Alopecia Areata
595 Patients Enrolled for Alopecia Areata

Media Library

Baricitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03570749 — Phase 2 & 3
Alopecia Areata Research Study Groups: Placebo, Open-Label Addenda Baricitinib High Dose, Baricitinib Low Dose, Baricitinib High Dose
Alopecia Areata Clinical Trial 2023: Baricitinib Highlights & Side Effects. Trial Name: NCT03570749 — Phase 2 & 3
Baricitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03570749 — Phase 2 & 3
Alopecia Areata Patient Testimony for trial: Trial Name: NCT03570749 — Phase 2 & 3
~116 spots leftby Nov 2025
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