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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:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36
Awards & highlights

BRAVE-AA1 Trial 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.Check my eligibility
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.See study design
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.

BRAVE-AA1 Trial 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.

BRAVE-AA1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
Secondary outcome measures
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
10%
Nasopharyngitis
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Headache
4%
Pharyngitis
3%
Alanine aminotransferase increased
3%
Back pain
3%
Erectile dysfunction
3%
Nausea
3%
Hypertension
2%
Diarrhoea
2%
Cough
2%
Dyspepsia
2%
Bronchitis
2%
Influenza
2%
Rash
1%
Hypercholesterolaemia
1%
Hyperlipidaemia
1%
Rheumatoid arthritis
1%
Anaemia
1%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adalimumab Treatment A
Baricitinib Follow-up
Placebo Follow-up
Placebo Treatment B
BaricitinibTreatment B
Adalimumab Treatment B
Baricitinib Treatment A
Adalimumab Follow-up
Placebo Treatment A
Rescue

BRAVE-AA1 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
2,612 Previous Clinical Trials
3,200,083 Total Patients Enrolled
3 Trials studying Alopecia Areata
1,156 Patients Enrolled for Alopecia Areata
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
54,341 Total Patients Enrolled
2 Trials studying Alopecia Areata
636 Patients Enrolled for Alopecia Areata
Study DirectorEli Lilly and Company
1,343 Previous Clinical Trials
404,406 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what illnesses is Baricitinib commonly prescribed?

"Baricitinib has shown efficacy in treating patients that are hospitalized with coronavirus disease 2019 (covid‑19) and require extracorporeal membrane oxygenation."

Answered by AI

Are there any vacancies in this clinical trial for participants?

"This trial is no longer recruiting participants. It was originally posted on September 24th, 2018 and last updated February 2nd, 2022. However, there are 93 other trials for alopecia areata and 34 for Baricitinib that are still looking for patients to enroll."

Answered by AI

What insights have been gleaned from prior research on Baricitinib?

"University of Nebraska Medical Center first researched baricitinib in 2007 and, since then, 18310 similar studies have been completed. As of now, there are 34 ongoing clinical trials with a large portion taking place in New Haven, Connecticut."

Answered by AI

To whom does this experiment offer the most potential benefit?

"This clinical trial is seeking 764 participants that suffer from alopecia areata. The study has the following age requirements: 18-70 for males and 18-70 for females. Additionally, applicants must meet the following other conditions: Current episode of severe or very severe AA of less than 8 years (participants who have severe or verysevere AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years), current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured"

Answered by AI

Are elderly patients welcome in this clinical trial?

"All individuals above the age of 18 and under 70 are eligible to participate in this trial."

Answered by AI

Is this study also being conducted in other countries besides the United States?

"Multiple locations across the United States are participating in this clinical trial, including but not limited to Yale University School of Medicine in New Haven, Connecticut and California Dermatology & Clinical Research Institute in Encinitas, Kentucky."

Answered by AI

How many people have been selected to participate in this trial?

"Unfortunately, this particular study is not currently admitting patients. Although, it was last updated on February 2nd, 2022. There are 93 other studies for alopecia areata and 34 for Baricitinib that are actively recruiting individuals right now."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
Georgia
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Dermatology Research Associates
Medaphase Inc
Austin Institute for Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have had Alopecia for years with no improvement. I have tried a verity of different medication and nothing works.
PatientReceived 2+ prior treatments
I've tried Finasteride and Minoxidil oral medication but did not work.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

I don’t have any questions, except for do I qualify?
PatientReceived 2+ prior treatments
Recent research and studies
New England Journal of MedicineJournal
Two Phase 3 Trials of Baricitinib for Alopecia Areata
King, Brett, Manabu Ohyama, Ohsang Kwon, Abraham Zlotogorski, Justin Ko, Natasha A. Mesinkovska, Maria Hordinsky, et al.. 2022. “Two Phase 3 Trials of Baricitinib for Alopecia Areata”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2110343.
New England Journal of MedicineJournal
Two Phase 3 Trials of Baricitinib for Alopecia Areata
King, Brett, Manabu Ohyama, Ohsang Kwon, Abraham Zlotogorski, Justin Ko, Natasha A. Mesinkovska, Maria Hordinsky, et al.. 2022. “Two Phase 3 Trials of Baricitinib for Alopecia Areata”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2110343.
clinicaltrials.govStudy
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
2018. "A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03570749.
All > Androgenetic Alopecia > Alopecia Areata
~127 spots leftby Apr 2025
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