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Janus Kinase (JAK) Inhibitor
Baricitinib for Pediatric Hair Loss (BRAVE-AA-PEDS Trial)
Phase 3
Recruiting
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
Must have severe areata alopecia (AA) for at least 1 year
Must have a diagnosis for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-vaccination to 4 weeks and 12 weeks post-vaccination
Awards & highlights
BRAVE-AA-PEDS Trial Summary
This trial will determine the effectiveness and safety of Baricitinib to treat hair loss in children 6-18 years old.
Who is the study for?
This trial is for children aged 6 to less than 18 with severe alopecia areata (AA), a hair loss condition. They must have tried at least one treatment without success, had AA for over a year, and experienced an ongoing episode of AA for at least six months. Those with uncontrolled high blood pressure, recent major surgery, hepatitis B or C infections, HIV infection, or other serious health issues cannot participate.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Baricitinib in treating severe alopecia areata in children. It includes a screening period followed by a double-blind treatment phase where participants randomly receive either Baricitinib or placebo without knowing which one they're getting.See study design
What are the potential side effects?
While not specified here, common side effects of Baricitinib may include respiratory infections like colds, nausea, headaches and increased cholesterol levels. Each child's experience can vary.
BRAVE-AA-PEDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had severe hair loss for at least a year.
Select...
I was diagnosed over a year ago.
Select...
I have had an AA episode for at least 6 months.
Select...
I have tried at least one treatment for alopecia areata without success.
BRAVE-AA-PEDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-vaccination to 4 weeks and 12 weeks post-vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-vaccination to 4 weeks and 12 weeks post-vaccination
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 an Absolute Severity of Alopecia Tool (SALT) ≤20
Secondary outcome measures
Change of Immunoglobulin G (IgG) Titers
Mean Change from Baseline in Family Dermatology Life Quality Index (FDLQI)
Mean Change from Baseline in Hospital Anxiety Depression Scale (HADS)
+17 moreSide effects data
From 2015 Phase 3 trial • 1307 Patients • NCT0171035810%
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
Adalimumab Treatment B
Placebo Treatment B
Baricitinib Follow-up
Baricitinib Treatment A
Placebo Follow-up
BaricitinibTreatment B
Adalimumab Follow-up
Placebo Treatment A
Rescue
BRAVE-AA-PEDS Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Baricitinib Low DoseExperimental Treatment1 Intervention
Participants will receive baricitinib low dose orally.
Group II: Baricitinib High DoseExperimental Treatment1 Intervention
Participants will receive baricitinib high dose orally.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
2017
Completed Phase 3
~9510
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,463 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,657 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not bedridden and can take care of myself.I have had severe alopecia areata for less than 8 years or have seen hair regrowth in the last 8 years.I have had severe hair loss for at least a year.I do not have any serious health issues that could risk my participation.I have tried at least one treatment for alopecia areata without success.My blood pressure is under control.I have had severe hair loss for at least a year.My hair loss is not mainly from all over my scalp.I do not have any other hair loss conditions besides alopecia areata.I have had severe alopecia areata for 8+ years but have seen some hair regrowth.I am between 12 and 18 years old, or between 6 and 12 years old.I haven't had major surgery in the last 8 weeks and don't need any during the study.I have had an AA episode for at least 6 months.I was diagnosed over a year ago.You have been experiencing ongoing episodes of AA (a type of medical condition) for at least 6 months.You have received counseling in the past for issues related to alcohol addiction.Your SALT score, which measures the severity of a skin condition called psoriasis, is 50% or higher at the time of screening and baseline.I have tried at least one treatment for alopecia areata without success.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Baricitinib Low Dose
- Group 3: Baricitinib High Dose
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Hair Loss Patient Testimony for trial: Trial Name: NCT05723198 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do individuals over the age of 35 qualify to participate in this medical research?
"Participants that wish to be part of this trial must fall between 6 and 17 years of age."
Answered by AI
How many institutions are overseeing this trial?
"This trial has 4 currently active sites, including Total Skin and Beauty Dermatology Center in Birmingham, Clarkston Skin Research in Clarkston, Texas Dermatology and Laser Specialists in San Antonio. There are also other locations that have been approved to participate."
Answered by AI
Has the highest dose of Baricitinib received approval from the Food and Drug Administration?
"Based on the Phase 3 trial results, there is sufficient evidence to assign a score of 3 out of 3 for Baricitinib High Dose's safety profile."
Answered by AI
Are there any current opportunities to participate in this clinical experiment?
"The clinical trial data available on clinicaltrials.gov does not indicate that this particular study is actively recruiting patients at the moment; it was first posted on February 28th 2023 and last edited about two weeks later. However, there are currently 128 other trials across various medical areas looking for candidates to participate in their research."
Answered by AI
What qualifications are needed for an individual to partake in this clinical trial?
"This research project seeks to enrol 595 alopecia patients, aged 6-17 years old. Eligible participants must have experienced severe AA for more than a year, current hair loss covering 50% of the scalp or higher according to SALT score, failed treatment with topical solutions and/or other treatments previously attempted, participated in psychological counselling related to their condition, and have had an episode of severe AA that has lasted less than 8 years (individuals who have suffered from it for 8+ may still be eligible if regrowth was observed over this period)."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Florida
Texas
What site did they apply to?
Investigate MD
Skin Care Research, Inc
Bexley Dermatology Research
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
Why did patients apply to this trial?
II lost mt hair 15 years ago,and at this point I willing to try anything. I would be happy if just my eyelashes and eyebrows came back!
PatientReceived 1 prior treatment
I am so self conscious since my hair loss and body scaring. I've never been a person with lack of confidence before these dermatology health issues.
PatientReceived 2+ prior treatments
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