Areata Alopecia study: Baricitinib
Official title A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
ClinicalTrials.gov ID: NCT05723198
What this study is testing
What is Baricitinib?
This is an investigational oral medicine being studied as a potential treatment for severe hair loss in children. It is designed to block specific signals in the immune system that may cause hair follicles to stop growing.
Also referred to as LY3009104.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if baricitinib is safe and effective for treating severe or very severe alopecia areata (a condition that causes hair loss) in children.
- Who it's for
- The study is looking for children between 6 years old and under 18 years old who have severe or very severe alopecia areata.
- What's involved
- Participants will take part in a 5-week screening, a 36-week treatment period where they receive the study drug or a placebo, and a long-term follow-up phase.
- Time commitment
- The study involves a 5-week screening, 36 weeks of treatment, and an approximately 2-year long-term extension, with some participants staying for up to 180 weeks.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years...
- Have severe areata alopecia (AA) for at least 1 year
- Diagnosis for at least 1 year
- Current AA episode of at least 6 months' duration
- SALT score ≥50% at screening and baseline
You likely can't join if
- Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
- Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss...
- Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
- Have uncontrolled arterial hypertension
- Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric...
See the full eligibility criteria
- Enrollment will be fully sequential by age group, with adolescents (12 to less than 18 years old) enrolling before children (6 to less than 12 years old).
- Have severe areata alopecia (AA) for at least 1 year
- Diagnosis for at least 1 year
- Current AA episode of at least 6 months' duration
- SALT score ≥50% at screening and baseline
- History of trial and failure with at least 1 available treatment (topical or other) for AA
- History of psychological counseling related to AA
- Current episode of severe AA of less than 8 years.
- Note: Participants who have severe 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.
- Primarily "diffuse" type of AA (characterized by diffuse hair shedding).
- Are currently experiencing other forms of alopecia including, but not limited to trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or any other concomitant conditions (for example, tinea capitis...
- Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden
- Have uncontrolled arterial hypertension
- Have had major surgery within 8 weeks prior to screening or will require major surgery during the study
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the...
- Have a positive test for hepatitis B virus (HBV) infection
- Have hepatitis C virus (HCV) infection (positive for anti hepatitis C antibody with confirmed presence of HCV ribonucleic acid [RNA]).
- Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Ana, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Macon, Georgia, United States
- Skokie, Illinois, United States
- Indianapolis, Indiana, United States
- South Bend, Indiana, United States
- Rockville, Maryland, United States
- Clarkston, Michigan, United States
- Minneapolis, Minnesota, United States
- Saint Joseph, Missouri, United States
- Omaha, Nebraska, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
- Bexley, Ohio, United States
+ 66 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Santa Ana, California, United States and 80 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.