A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Launched by ELI LILLY AND COMPANY · Sep 26, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called lebrikizumab to see how well it works for children and teenagers aged 6 months to under 18 years who have moderate-to-severe atopic dermatitis, commonly known as eczema. The goal is to find out how effective and safe this treatment is, as well as how the body absorbs it. If your child has had a confirmed diagnosis of atopic dermatitis for at least 6 to 12 months, depending on their age, and has a specific level of skin involvement, they might be eligible to participate in this study.
Participants in the trial can expect to undergo regular assessments to monitor their skin condition and any side effects from the medication. It's important to note that some children may not qualify if they have been involved in other clinical studies recently or have received certain treatments within specific time frames. This trial is currently recruiting participants, and it provides a chance to potentially help improve treatment options for atopic dermatitis in younger patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
- • 12 months if participants are ≥6 years of age
- • 6 months if participants are 2 to \<6 years of age
- • 3 months if participants are 6 months to \<2 years of age.
- • Have an EASI score ≥16 at the screening and baseline
- • Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
- • Have ≥10% BSA of AD involvement at the screening and baseline.
- Exclusion Criteria:
- • Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
- * Treatment with the following prior to the baseline:
- • An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
- • Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%.
- • Treatment with a topical investigational drug within 2 weeks prior to the baseline.
- • Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
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
Boston, Massachusetts, United States
Milwaukee, Wisconsin, United States
Charleston, South Carolina, United States
Randwick, New South Wales, Australia
Madrid, , Spain
Phoenix, Arizona, United States
Madrid, , Spain
Houston, Texas, United States
Westmead, New South Wales, Australia
Lebanon, New Hampshire, United States
Bay City, Michigan, United States
Hiroshima, , Japan
Madrid, , Spain
Taipei, , Taiwan
Lebanon, New Hampshire, United States
Fukuyama, Hiroshima, Japan
Asahikawa, Hokkaido, Japan
Los Angeles, California, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Ypsilanti, Michigan, United States
Praha 10, , Czechia
Sagamihara, Kanagawa, Japan
Madrid, , Spain
Taoyuan, , Taiwan
Bad Bentheim, Niedersachsen, Germany
Kyoto, , Japan
Taipei, , Taiwan
Pamplona, Navarra, Spain
Pamplona, , Spain
Praha 10, , Czechia
Taipei City, Taipei, Taiwan
Gdansk, Pomorskie, Poland
Birmingham, Alabama, United States
Madrid, , Spain
Frankfurt, Hessen, Germany
San Antonio, Texas, United States
Woolloongabba, Queensland, Australia
Randwick, New South Wales, Australia
Woolloongabba, Queensland, Australia
Habikino, Osaka, Japan
Münster, Nordrhein Westfalen, Germany
Pozuelo De Alarcon, Madrid, Spain
Monterrey, Nuevo León, Mexico
Tampa, Florida, United States
Toyoake, Aichi, Japan
Lancaster, California, United States
Lodz, , Poland
Fairborn, Ohio, United States
Sakai City, Osaka, Japan
Fountain Valley, California, United States
Houston, Texas, United States
Jacksonville, Florida, United States
Olomouc, , Czechia
Krakow, , Poland
Boise, Idaho, United States
Edmonton, Alberta, Canada
Mississauga, Ontario, Canada
Santo Andre, , Brazil
Rosario, Santa Fe, Argentina
Chihuahua, , Mexico
Tampa, Florida, United States
Exton, Pennsylvania, United States
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Darmstadt, Hessen, Germany
Kyoto, , Japan
Warsaw, Mazowieckie, Poland
Hsinchu, , Taiwan
Monterrey, Nuevo León, Mexico
Esplugues De Llobregat, , Spain
Brno, , Czechia
Sacramento, California, United States
Auburn Hills, Michigan, United States
Okayama, , Japan
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Sakai City, Osaka, Japan
Krakow, Małopolskie, Poland
Taipei City, Beitou District, Taiwan
Taipei City, Taipei, Taiwan
Ciudad Autónoma De Buenos Aire, Buenos Aires, Argentina
Calgary, Alberta, Canada
Bramsche, Niedersachsen, Germany
Esplugues De Llobregat, Barcelona [Barcelona], Spain
Barretos, São Paulo, Brazil
Hradec Kralove, Hradec Králové, Czechia
Rio De Janeiro, , Brazil
Bellaire, Texas, United States
Campinas, São Paulo, Brazil
Santo André, São Paulo, Brazil
Veracruz, , Mexico
Prague, Praha 8, Czechia
Sorocaba, São Paulo, Brazil
Monterrey, Nuevo León, Mexico
Buenos Aires, , Argentina
Mexico City, Distrito Federal, Mexico
Taichung City, Taichung, Taiwan
Dresden, Sachsen, Germany
Taipei, , Taiwan
Rosario, Santa Fe, Argentina
Monterrey, Nuevo León, Mexico
Ribeirão Preto, São Paulo, Brazil
Buenos Aires, , Argentina
North Little Rock, Arkansas, United States
Farmington, Connecticut, United States
Owensboro, Kentucky, United States
Caledonia, Michigan, United States
Buenos Aires, Ciudad Aut, Argentina
Buenos Aires, , Argentina
Brno, Brno Město, Czechia
Romans Sur Isère, Drôme, France
Rennes, Ille Et Vilaine, France
Nantes, Loire Atlantique, France
Toulouse, Midi Pyrénées, France
Lille, Nord Pas De Calais, France
Sagamihara, Kanagawa, Japan
Ina, Nagano, Japan
Kumagaya, Saitama, Japan
Toshima, Tokyo, Japan
Mexico City, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Cuernavaca, Morelos, Mexico
Lodz, łódzkie, Poland
Las, Las Palmas, Spain
Pontevedra, Pontevedra [Pontevedra], Spain
Manises, València, Spain
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Prague, Praha 8, Czechia
Rio De Janeiro, , Brazil
Pontevedra, Pontevedra [Pontevedra], Spain
Ciudad Autónoma De Buenos Aire, Buenos Air, Argentina
Buenos Aires, Buenos Air, Argentina
Ciudad Autonoma De Buenos Aire, Buenos Air, Argentina
Ciudad Autonoma De Buenos Aire, Buenos Air, Argentina
Ciudad Autónoma De Buenos Aire, Buenos Air, Argentina
Campinas, São Paulo, Brazil
Ribeirão Preto, São Paulo, Brazil
Sacramento, California, United States
Nantes, Loire Atlantique, France
Santo Andre, São Paulo, Brazil
Coorparoo, Queensland, Australia
Chihuahua, , Mexico
Bad Bentheim, Niedersach, Germany
Lodz, łódzkie, Poland
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Madrid, , Spain
Monterrey, , Mexico
Zapopan, Jalisco, Mexico
Ciudad Autónoma De Buenos Aires, , Argentina
Veracruz, , Mexico
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Prague, , Czechia
Barretos, , Brazil
Monterrey, , Mexico
Ribeirão Preto, , Brazil
Campinas, , Brazil
Sorocaba, , Brazil
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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