A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Launched by ELI LILLY AND COMPANY · Feb 10, 2023
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
- • For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Exclusion Criteria:
- • Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- • Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
- • Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)
- • Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.
- • Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
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
Taipei, , Taiwan
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
Buenos Aires, , Argentina
Ypsilanti, Michigan, United States
Praha 10, , Czechia
Sagamihara, Kanagawa, Japan
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
Manises, , Spain
Woolloongabba, Queensland, Australia
Habikino, Osaka, Japan
Münster, Nordrhein Westfalen, Germany
Farmington, Connecticut, United States
Pozuelo De Alarcon, Madrid, Spain
Monterrey, Nuevo León, Mexico
Tampa, Florida, United States
Toyoake, Aichi, Japan
Lancaster, California, United States
Fairborn, Ohio, United States
Sakai City, Osaka, Japan
Fountain Valley, California, United States
Jacksonville, Florida, United States
Krakow, , Poland
Santo André, , Brazil
Boise, Idaho, United States
Edmonton, Alberta, Canada
Mississauga, Ontario, Canada
Lodz, , Poland
Santo Andre, , Brazil
Madrid, , Spain
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
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
Calgary, Alberta, Canada
Bramsche, Niedersachsen, Germany
Esplugues De Llobregat, Barcelona [Barcelona], Spain
Barretos, São Paulo, Brazil
Hradec Kralove, Hradec Králové, Czechia
Bellaire, Texas, United States
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
Owensboro, Kentucky, United States
Caledonia, Michigan, United States
Buenos Aires, Ciudad Aut, Argentina
Brno, Brno Město, Czechia
Olomouc, Olomoucký Kraj, 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
Campinas, São Paulo, Brazil
Taipei, , Taiwan
Krakow, Małopolski, Poland
Sacramento, California, United States
Nantes, Loire Atlantique, France
Santo Andre, São Paulo, Brazil
Coorparoo, Queensland, Australia
Toulouse, , France
Chihuahua, , Mexico
Bad Bentheim, Niedersach, Germany
Lodz, łódzkie, Poland
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Madrid, , Spain
Monterrey, , Mexico
Zapopan, Jalisco, Mexico
Prague, , Czechia
Barretos, , Brazil
Monterrey, , Mexico
Pontevedra, , Spain
Ribeirão Preto, , Brazil
Campinas, , Brazil
Sorocaba, , Brazil
Romans Sur Isère, , France
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
Similar Trials