Your session is about to expire
← Back to Search
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
Be younger than 18 years old
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 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 • NCT017103586%
Nasopharyngitis
3%
Upper respiratory tract infection
3%
Bronchitis
2%
Influenza
2%
Back pain
2%
Urinary tract infection
1%
Pharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
BaricitinibTreatment B
Adalimumab Treatment A
Placebo Follow-up
Baricitinib Follow-up
Baricitinib Treatment A
Placebo Treatment B
Adalimumab Treatment 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
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, particularly JAK inhibitors like Baricitinib, work by interfering with the JAK-STAT signaling pathway, which is involved in the immune response that attacks hair follicles. By inhibiting this pathway, these drugs reduce inflammation and autoimmunity, promoting hair regrowth.
Other treatments, such as cyclosporine and methotrexate, also modulate the immune system but through different mechanisms, such as inhibiting T-cell activation or folate metabolism, respectively. Understanding these mechanisms is crucial for patients as it helps tailor treatments to their specific immune profiles, potentially improving efficacy and reducing side effects.
Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?
Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,334 Total Patients Enrolled
3 Trials studying Alopecia Areata
1,385 Patients Enrolled for Alopecia Areata
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,063 Total Patients Enrolled
1 Trials studying Alopecia Areata
824 Patients Enrolled for Alopecia Areata
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.
Alopecia Areata Patient Testimony for trial: Trial Name: NCT05723198 — Phase 3
Share this study with friends
Copy Link
Messenger