Actively Recruiting
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Led by Eli Lilly and Company · Updated on 2026-03-03
60
Participants Needed
34
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
CONDITIONS
Official Title
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females weighing at least 10 kg and aged 2 to less than 18 years at screening
- Diagnosed with moderate to severe ulcerative colitis
- Have not responded to corticosteroids, biologics (such as anti-TNF or anti-integrin antibodies), immunomodulators (such as azathioprine, thiopurines, or methotrexate), or JAK-Inhibitor treatments
- Have had ulcerative colitis for at least 3 months before baseline, confirmed by endoscopy and histopathology
You will not qualify if you...
- Diagnosis of 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 gastrointestinal tract cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
University of California, San Francisco
San Francisco, California, United States, 94158
Completed
2
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States, 30342
Completed
3
Riley Childrens Hospital
Indianapolis, Indiana, United States, 46202
Completed
4
Washington University
St Louis, Missouri, United States, 63110-1010
Completed
5
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Completed
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
UZA
Edegem, Belgium, 2650
Completed
8
UZ Leuven
Leuven, Belgium, 3000
Completed
9
The Hospital for Sick Children
Toronto, Canada, M5G 0A4
Completed
10
Hôpital Necker - Enfants Malades
Paris, France, 75015
Completed
11
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Germany, 55131
Completed
12
LMU-Campus Innenstadt
München, Germany, 80337
Completed
13
Helios Klinikum Wuppertal
Wuppertal, Germany, 42283
Completed
14
Shaare Zedek
Jerusalem, Israel, 9103102
Completed
15
Hadassah University Hospital, Ein Kerem
Jerusalem, Israel, 911200
Completed
16
Schneider Children's Medical Center
Petah Tikva, Israel, 4920235
Completed
17
King Fahad Medical City
Rishon LeZiyyon, Israel, 70300
Completed
18
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, Italy, 50139
Completed
19
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, Italy, 00161
Completed
20
Juntendo University Hospital
Bunkyō City, Japan, 113-8431
Completed
21
Institute of Science Tokyo Hospital
Bunkyō City, Japan, 113-8519
Completed
22
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Japan, 277-0871
Completed
23
Saga University Hospital
Saga, Japan, 849-8501
Completed
24
National Center for Child Health and Development
Setagaya-ku, Japan, 157-8535
Completed
25
Yokohama City University Medical Center, Center of IBD
Yokohama, Japan, 232-0024
Completed
26
Gabinet Lekarski Bartosz Korczowski
Rzeszów, Poland, 35-302
Completed
27
Twoja Przychodnia-Szczecińskie Centrum Medyczne
Szczecin, Poland, 71-434
Completed
28
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 04-501
Completed
29
Instytut 'Pomnik - Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Completed
30
Centrum Medyczne Oporow
Wroclaw, Poland, 52-416
Completed
31
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Completed
32
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Completed
33
Samsung Medical Center
Seoul, South Korea, 06351
Completed
34
Sheffield Children's Hospital
Sheffield, United Kingdom, S102TH
Completed
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here