A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
Launched by ELI LILLY AND COMPANY · Feb 3, 2023
Trial Information
Current as of June 17, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called baricitinib to see if it can help children aged 6 to under 18 who have severe hair loss due to a condition called alopecia areata. The main goal is to find out if this treatment is both effective and safe for these young patients. The study will take place over several phases, beginning with a 5-week screening period, followed by a 36-week treatment phase where some participants will receive the medication while others will receive a placebo (a treatment that looks the same but has no active ingredients). After that, there will be a long-term follow-up period lasting about 2 years to gather more information.
To be eligible for the trial, children must have had severe alopecia areata for at least one year and have experienced hair loss for at least six months. They should also have a specific score that measures the extent of their hair loss and must have tried at least one other treatment without success. However, children with certain other medical conditions or types of hair loss won't be able to participate. If eligible, participants can expect regular check-ups and monitoring throughout the study, which aims to find better treatments for alopecia areata in children.
Gender
ALL
Eligibility criteria
- Inclusion 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.
- Exclusion Criteria:
- • 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, psoriasis, lupus erythematosus, or secondary syphilis) that would interfere with evaluations of the effect of study medication on AA.
- • 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 opinion of the investigator, could constitute an unacceptable risk when taking IP or interfere with the interpretation of data.
- • 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.
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Birmingham, Alabama, United States
Charleston, South Carolina, United States
Bronx, New York, United States
Minneapolis, Minnesota, United States
Madrid, , Spain
Barcelona, , Spain
Cincinnati, Ohio, United States
Taipei, , Taiwan
Alicante, , Spain
Badalona, , Spain
Valencia, , Spain
St Leonards, New South Wales, Australia
Bay City, Michigan, United States
Bilbao, Vizcaya, Spain
Taipei, , Taiwan
Dresden, , Germany
Hamamatsu, Shizuoka, Japan
Dresden, , Germany
Bad Bentheim, , Germany
Tainan, , Taiwan
Osaka, , Japan
Hamburg, , Germany
Kurume, Fukuoka, Japan
Mitaka, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Tainan, , Taiwan
Los Angeles, California, United States
Seoul, , Korea, Republic Of
Hamburg, , Germany
Muenster, , Germany
Indianapolis, Indiana, United States
Surrey, British Columbia, Canada
Winnipeg, Manitoba, Canada
Markham, Ontario, Canada
Seoul, , Korea, Republic Of
Lübeck, Schleswig Holstein, Germany
Warszawa, , Poland
Niigata, , Japan
Cleveland, Ohio, United States
Taoyuan, , Taiwan
Bad Bentheim, Niedersachsen, Germany
Skokie, Illinois, United States
Ube, Yamaguchi, Japan
Taipei, , Taiwan
Dallas, Texas, United States
Pamplona, , Spain
Seoul, , Korea, Republic Of
Madison, Wisconsin, United States
Norfolk, Virginia, United States
Tulsa, Oklahoma, United States
Gdansk, Pomorskie, Poland
Saint Leonards, New South Wales, Australia
Madrid, , Spain
Dresden, Sachsen, Germany
Pilar, Buenos Aires, Argentina
Birmingham, Alabama, United States
Saint Joseph, Missouri, United States
Seoul, , Korea, Republic Of
Kaposvár, Somogy, Hungary
Boca Raton, Florida, United States
Seoul, , Korea, Republic Of
Tulsa, Oklahoma, United States
San M. De Tucuman, Tucumán, Argentina
Suwon, Gyeonggi Do, Korea, Republic Of
Daegu, Korea, Korea, Republic Of
Incheon, Korea, Korea, Republic Of
Taichung City, , Taiwan
Miami, Florida, United States
Budapest, , Hungary
Jacksonville, Florida, United States
Pflugerville, Texas, United States
Encinitas, California, United States
San Antonio, Texas, United States
Luebeck, , Germany
Woolloongabba, Queensland, Australia
Pecs, , Hungary
Clarkston, Michigan, United States
Pflugerville, Texas, United States
Daejeon, , Korea, Republic Of
Seongnam Si, Geonggi Do, Korea, Republic Of
Omaha, Nebraska, United States
Santa Ana, California, United States
Woolloongabba, Queensland, Australia
Norfolk, Virginia, United States
Toronto, Ontario, Canada
Portland, Oregon, United States
Gdansk, , Poland
Melbourne, Victoria, Australia
Katowice, , Poland
Pozuelo De Alarcon, Madrid, Spain
Tampa, Florida, United States
Charlotte, North Carolina, United States
Buenos Aires, , Argentina
Debrecen, Hajdu Bihar, Hungary
Pecs, , Hungary
Jacksonville, Florida, United States
Charlotte, North Carolina, United States
Murfreesboro, Tennessee, United States
Seoul, , Korea, Republic Of
Nice Cedex 3, , France
Monterrey, Nuevo León, Mexico
Coral Gables, Florida, United States
Ostrowiec Swietokrzyski, , Poland
South Bend, Indiana, United States
Mainz, , Germany
München, Bayern, Germany
Bexley, Ohio, United States
Murray, Utah, United States
Rockville, Maryland, United States
Caba, Buenos Aires, Argentina
Bilbao, , Spain
Cheonan Si, Chungcheongnam Do, Korea, Republic Of
Tampa, Florida, United States
Exton, Pennsylvania, United States
Katowice, śląskie, Poland
Macon, Georgia, United States
Marseille, , France
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Scottsdale, Arizona, United States
Warszawa, , Poland
Frankfurt Am Main, , Germany
Berlin, , Germany
Incheon, Incheon Gwangyeoksi [Incheon], Korea, Republic Of
Warszawa, , Poland
Cobourg, Ontario, Canada
Debrecen, Hajdu Bihar, Hungary
Seoul, Korea, Korea, Republic Of
Monterrey, Nl, Mexico
Madrid, , Spain
Busan, Pusan Kwangyǒkshi, Korea, Republic Of
Daejeon, Jung Gu, Korea, Republic Of
Wroclaw, , Poland
San Miguel De Tucumán, Tucumán, Argentina
San Diego, California, United States
Coral Gables, Florida, United States
Lodz, Lodzkie, Poland
Katowice, , Poland
Clarkston, Michigan, United States
Calgary, Alberta, Canada
Nantes, , France
Kielce, , Poland
Rzeszow, , Poland
Warszawa, , Poland
Bilbao (Bizkaia), , Spain
Madrid, , Spain
Luebeck, Schleswig Holstein, Germany
Hollywood, Florida, United States
Portland, Oregon, United States
Bialystok, , Poland
Szczecin, , Poland
Jeonju Si, , Korea, Republic Of
Veracruz, , Mexico
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Taichung City, Taichung, Taiwan
Jung Gu, Taegu Kwangyǒkshi, Korea, Republic Of
Monterrey, Nuevo León, Mexico
Buenos Aires, Buenos Air, Argentina
Sugar Land, Texas, United States
Barcelona, , Spain
Debrecen, , Hungary
Badalona, , Spain
Warsaw, Małopolskie, Poland
Nice, , France
Bydgoszcz, , Poland
Kaposvar, Somogy, Hungary
Katowice, śląskie, Poland
Doral, Florida, United States
Grapevine, Texas, United States
Paris, , France
Halle, , Germany
Hamburg, , Germany
Muenchen, , Germany
Szeged, Csongrad, Hungary
Warsaw, Masovian, Poland
Madrid, , Spain
Pozuelo De Alarcon, , Spain
Valencia, , Spain
Brest Cedex 2, , France
Krakow, Malopolskie, Poland
Kielce, , Poland
Warszawa, , Poland
New Taipei City, New Taipei, Taiwan
Taoyuan County, , Taiwan
Darlinghurst, New South Wales, Australia
Mitcham, Victoria, Australia
Cheonan Si, Chungcheongnam Do [Chungnam], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Daejeon, , Korea, Republic Of
Budapest, , Hungary
Murfreesboro, Tennessee, United States
Rockville, Maryland, United States
Darlinghurst, New South Wales, Australia
Tours Cedex, , France
Muenchen, , Germany
Kurume, Fukuoka, Japan
Cheonan, Chungcheongnam Do [Chungnam], Korea, Republic Of
Daejeon, Jung Gu, Korea, Republic Of
Seoul, Seoul, Korea, Korea, Republic Of
Nice, , France
San Francisco, California, United States
Fairfield, Connecticut, United States
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
San Miguel De Tucuman, Provincia De Tucuman, Argentina
Muenchen, Bayern, Germany
Muenster, , Germany
Miyagi Gun, Miyagi, Japan
Jung Gu, Taegu Kwangyǒkshi, Korea, Republic Of
Guadalajara, Jalisco, Mexico
Chihuahua, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Rzeszow, Podkarpackie, Poland
Barcelona, Catalunya [Cataluña], Spain
Taichung City, Taichung, Taiwan
Taoyuan, , Taiwan
Nice, , France
Birmingham, Alabama, United States
Brest Cedex 2, , France
Marseille, , France
Seoul, , Korea, Republic Of
Kielce, , Poland
Barcelona, Catalunya [Cataluña], Spain
Warsaw, Małopolskie, Poland
Warszawa, , Poland
Darlinghurst, New South Wales, Australia
Wooloongabba, Queensland, Australia
Frankfurt Am Main, , Germany
Szeged, , Hungary
Suwon City, Gyeonggido, Korea, Republic Of
Krakow, Malopolskie, Poland
Rzeszow, Podkarpackie, Poland
Bialystok, , Poland
Bydgoszcz, , Poland
Katowice, , Poland
Swietokrzyski, , Poland
Warszawa, , Poland
Warszawa, , Poland
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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