A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Launched by ELI LILLY AND COMPANY · Mar 13, 2023
Trial Information
Current as of October 15, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called Mirikizumab to see how well it works for children and teenagers who have moderately to severely active ulcerative colitis (UC). Ulcerative colitis is a condition that causes inflammation in the intestines, leading to symptoms like stomach pain and diarrhea. The main goal of this study is to find out if Mirikizumab is safe and effective for young patients who have not responded to other treatments, such as steroids or other medications.
To participate in the trial, children must be between 2 and 17 years old, weigh at least 10 kg, and have had ulcerative colitis for at least 3 months. They should have tried and not done well with other treatments before joining the study. Participants will receive the study medication and will be closely monitored to see how they respond. This trial is currently looking for participants, and it’s important for families to know that their child's health and safety will be prioritized throughout the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening.
- • Have moderate to severe UC.
- • Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
- • Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.
- Exclusion Criteria:
- • Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
- • Have immune deficiency syndrome.
- • Previous bowel resection or intestinal surgery.
- • Evidence of toxic megacolon.
- • History or current evidence of cancer of the gastrointestinal tract.
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
San Francisco, California, United States
Saint Louis, Missouri, United States
Halifax, Nova Scotia, Canada
Cincinnati, Ohio, United States
Los Angeles, California, United States
Hartford, Connecticut, United States
Saint Louis, Missouri, United States
Aurora, Colorado, United States
Morristown, New Jersey, United States
London, United Kingdom
Cincinnati, Ohio, United States
New York, New York, United States
Boston, Massachusetts, United States
Toronto, Ontario, Canada
Sheffield, United Kingdom
Paris, France
Leuven, Belgium
Rotterdam, Netherlands
Seoul, Korea, Republic Of
Seoul, Korea, Republic Of
Bunkyo Ku, Tokyo, Japan
Vancouver, British Columbia, Canada
Palo Alto, California, United States
Bunkyo Ku, Tokyo, Japan
Seoul, Korea, Republic Of
Indianapolis, Indiana, United States
Paris, France
Sheffield, South Yorkshire, United Kingdom
Erlangen, Germany
Jerusalem, Israel
San Diego, California, United States
Wuppertal, Germany
Roma, Italy
Edegem, Belgium
Mainz, Germany
Setagaya Ku, Tokyo, Japan
Saga, Japan
Haifa, Israel
Amsterdam, Netherlands
Braga, Portugal
Daegu, Korea, Republic Of
Braga, Portugal
Bunkyo Ku, Japan
Rishon Lezion, Israel
Indianapolis, Indiana, United States
Busan, Korea, Republic Of
San Francisco, California, United States
Boston, Massachusetts, United States
Porto, Portugal
South Brisbane, Queensland, Australia
Jerusalem, Israel
Warszawa, Poland
Petach Tikva, Israel
London, United Kingdom
Roma, Italy
Houston, Texas, United States
Nedlands, Western Australia, Australia
Rzeszow, Poland
Wroclaw, Poland
Warszawa, Poland
Saga Shi, Japan
Rotterdam, Netherlands
Firenze, Italy
Rzeszow, Poland
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Atlanta, Georgia, United States
Toronto, Canada
Tsu Shi, Japan
North Adelaide, South Australia, Australia
Setagaya Ku, Japan
Bunkyō, Tokyo, Japan
Saint Louis, Missouri, United States
Greenville, South Carolina, United States
Atlanta, Georgia, United States
Tsu Shi, Mie Ken, Japan
Seoul, Korea, Korea, Republic Of
Amsterdam, Netherlands
Takatsuki Shi, Japan
Daegu, Kwangyǒkshi, Korea, Republic Of
London, Ontario, Canada
Morristown, New Jersey, United States
Braga, Portugal
Kashiwa Shi, Chiba Ken, Japan
Szczecin, Poland
Muenchen, Bayern, Germany
San Francisco, California, United States
Edegem, Belgium
Vancouver, British Colombia, Canada
Amiens, Somme, France
Bron, France
Müenchen, Bavaria, Germany
Wuppertal, Nordrhein Westfalen, Germany
Mainz, Rheinland Pfalz, Germany
Roma, Lazio, Italy
Florence, Italy
Yokohama, Kanagawa, Japan
Warszawa, Mazowieckie, Poland
Amiens, Somme, France
Jerusalem, Israel
Yokohama Shi, Kanagawa Ken, Japan
Krakow, Poland
Porto, Portugal
Whitechapel, Greater London, United Kingdom
Los Angeles, California, United States
Bron, Rhone, France
Amiens, Somme, France
Bunkyō Ku, Tokyo, Japan
Daegu, Gyeongsangbuk Do, Korea, Republic Of
Szczecin, Poland
Warszawa, Poland
Bron, Rhone, France
Mainz, Rheinland Pfalz, Germany
Jerusalem, Yerushalayim, Israel
Zerifin, Israel
Daegu, Kwangyǒkshi, Korea, Republic Of
Whitechapel, Greater London, United Kingdom
Wroclaw, Poland
London, United Kingdom
Greenville, South Carolina, United States
Bron, France
Deagu, Taegu Kwangyǒkshi, Korea, Republic Of
Warszaw, Poland
Porto, Portugal
Deagu, Korea, Republic Of
San Diego, California, United States
Halifax, Canada
London, Canada
Amiens Cedex 1, France
Bron Cedex, France
Munchen, Germany
Jerusalem, Israel
Rishon Lezion, Israel
Bunkyo Ku, Japan
Kashiwa Shi, Japan
Yokohama Shi, Japan
Szczecin, Poland
Warszawa, Poland
Warszawa, Poland
Porto, Portugal
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