A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Launched by ELI LILLY AND COMPANY · Aug 19, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called mirikizumab in children and adolescents with Crohn's disease, a condition that causes inflammation in the digestive tract. The main goal is to see how well mirikizumab works, how safe it is, and how the body absorbs it. Participants in the study will be randomly assigned to receive either mirikizumab or a different treatment. The trial lasts about 74 weeks and includes different phases: a 12-week period to see how well the treatment works, a maintenance period from weeks 12 to 52 where ongoing effects are observed, and a follow-up period for safety checks.
To join the study, participants must be between 2 and 17 years old and have been diagnosed with Crohn's disease. They should have moderate to severe symptoms and have not responded well to at least one previous medication for Crohn's. However, those with certain complications like strictures (narrowing of the intestine) or recent surgeries are not eligible. Throughout the study, participants will have up to 19 visits to monitor their health and response to the treatment. It's an important opportunity for children with Crohn's disease to potentially benefit from a new therapy while contributing to medical research.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
- • Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).
- • Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
- • Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
- Exclusion Criteria:
- • Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
- • Participants must not have an abscess.
- • Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
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
Philadelphia, Pennsylvania, United States
Brussels, , Belgium
Los Angeles, California, United States
Halifax, Nova Scotia, Canada
La Jolla, California, United States
Atlanta, Georgia, United States
Houston, Texas, United States
Hartford, Connecticut, United States
Phoenix, Arizona, United States
Fort Worth, Texas, United States
Seattle, Washington, United States
Westmead, New South Wales, Australia
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
New York, New York, United States
Los Angeles, California, United States
Boston, Massachusetts, United States
Toronto, Ontario, Canada
Burlington, Vermont, United States
Little Rock, Arkansas, United States
Gent, , Belgium
Cordoba, , Spain
Leuven, , Belgium
Kobe, Hyogo, Japan
Rotterdam, , Netherlands
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bunkyo Ku, Tokyo, Japan
Sabadell, Barcelona, Spain
Vancouver, British Columbia, Canada
Seoul, , Korea, Republic Of
Indianapolis, Indiana, United States
Paris, , France
Sheffield, South Yorkshire, United Kingdom
Beer Sheva, , Israel
Porto Alegre, , Brazil
Jerusalem, , Israel
Morristown, New Jersey, United States
Roma, , Italy
Esplugues De Llobregat, Barcelona, Spain
London, , United Kingdom
Setagaya Ku, Tokyo, Japan
Philadelphia, Pennsylvania, United States
Brussel, , Belgium
London, , United Kingdom
Saga, , Japan
Haifa, , Israel
New York, New York, United States
Braga, , Portugal
Manchester, Greater Manchester, United Kingdom
Bruxelles, Brussel, Belgium
Lisboa, , Portugal
Busan, , Korea, Republic Of
New York, New York, United States
South Brisbane, Queensland, Australia
Jerusalem, , Israel
Bergamo, , Italy
Miami, Florida, United States
Warszawa, , Poland
Roma, , Italy
Houston, Texas, United States
Nedlands, Western Australia, Australia
Rzeszow, , Poland
Rotterdam, , Netherlands
Ribeirão Preto, São Paulo, Brazil
Firenze, , Italy
Paris, , France
València, , Spain
North Adelaide, South Australia, Australia
Manchester, Greater Manchester, United Kingdom
Petah Tiqva, , Israel
Daegu, Gyeongsangbuk Do, Korea, Republic Of
Manchester, , United Kingdom
Campinas, São Paulo, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Campinas, Sao Paulo, Brazil
Atlanta, Georgia, United States
Ribeirao Preto, São Paulo, Brazil
Bologna, , Italy
Daegu, Kwangyǒkshi, Korea, Republic Of
London, Ontario, Canada
Votuporanga, São Paulo, Brazil
Oslo, , Norway
Hartford, Connecticut, United States
Braga, , Portugal
Kashiwa Shi, Chiba Ken, Japan
San Francisco, California, United States
London, London, City Of, United Kingdom
Petah Tikva, Hamerkaz, Israel
San Francisco, California, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
New York, New York, United States
Milwaukee, Wisconsin, United States
Vienna, , Austria
Gent, Oost Vlaanderen, Belgium
Vitória, Espírito Santo, Brazil
Goiânia, Goiás, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Amines, Cedex1, France
Lille Cedex, Nord, France
Beer Sheva, Hadarom, Israel
Israel, , Israel
Jerusalem, , Israel
Hirosaki, Aomori Pref, Japan
Yokohama Shi, Kanagawa Ken, Japan
Sendai Shi, Miyagi, Japan
Setagaya Ku, Tokyo, Japan
Nordbyagen, , Norway
Tromsø, , Norway
Trondheim, , Norway
Warszawa, Masovian, Poland
Krakow, , Poland
Porto, , Portugal
Oxford, Gb Oxf, United Kingdom
Whitechapel, Greater London, United Kingdom
Edinburgh, Lothian Region, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Gent, , Belgium
Sao Paulo, Paraná, Brazil
Jerusalem, , Israel
Petah Tikva, , Israel
Hirosaki, Aomori Pref., Japan
Bergamo, , Italy
Firenze, , Italy
Roma, , Italy
Paris, , France
Bologna, , Italy
Dayton, Ohio, United States
Amines, Cedex1, France
Nordbyagen, , Norway
Trondheim, , Norway
Oxford, Gb Oxf, United Kingdom
Milano, , Italy
Rotterdam, Zuid Holland, Netherlands
Vitória, Espírito Santo, Brazil
Goiânia, Goiás, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Campinas, Sao Paulo, Brazil
Morristown, New Jersey, United States
Sao Paulo, Paraná, Brazil
Goiânia, , Brazil
Votuporanga, Sao Paulo, Brazil
Curitiba Pr, , Brazil
Santos Dumont, , Brazil
Amiens, , France
Jerusalem, , Israel
Headington, Oxford, United Kingdom
New York, New York, United States
Seoul, , Korea, Republic Of
Campinas, , 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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