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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36
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 moreTrial 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
~9020
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,465,560 Total Patients Enrolled
3 Trials studying Alopecia Areata
1,156 Patients Enrolled for Alopecia Areata
Incyte CorporationIndustry Sponsor
393 Previous Clinical Trials
63,142 Total Patients Enrolled
2 Trials studying Alopecia Areata
636 Patients Enrolled for Alopecia Areata
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,017 Total Patients Enrolled
1 Trials studying Alopecia Areata
595 Patients Enrolled for Alopecia Areata
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had severe hair loss for less than 8 years, or I've seen hair regrowth in the last 8 years if it's been longer.My alopecia areata is mainly of the diffuse type.I don't have other hair loss conditions affecting the study's evaluation.I took a JAK inhibitor for over 12 weeks without significant hair growth.I am a male aged 18-60 or a female aged 18-70.My condition is classified as severe or very severe AA.My condition has not gotten better on its own in the last 6 months.I have had significant hair loss for over 6 months.I have had severe scalp hair loss for over 6 months.My severe hair loss started less than 8 years ago.I am a man or a woman not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Open-Label Addenda Baricitinib High Dose
- Group 3: Baricitinib Low Dose
- Group 4: Baricitinib High Dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alopecia Areata Patient Testimony for trial: Trial Name: NCT03570749 — Phase 2 & 3