A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
NCT ID: NCT04004611
Last Updated: 2024-03-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2020-05-18
2023-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
NCT05784246
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
NCT05767021
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
NCT03518086
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
NCT02589665
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
NCT05509777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
Mirikizumab
Administered IV and SC
Open Label Induction Period: 10 mg/kg Miri IV
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Mirikizumab
Administered IV and SC
Open Label Induction Period: 300 mg Miri IV
Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Mirikizumab
Administered IV and SC
Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
Mirikizumab
Administered IV and SC
Open Label Maintenance Period: 100 mg Miri SC
Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Mirikizumab
Administered IV and SC
Open Label Maintenance Period: 200 mg Miri SC
Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Mirikizumab
Administered IV and SC
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC
Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Mirikizumab
Administered IV and SC
Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Mirikizumab
Administered IV and SC
Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC
Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Mirikizumab
Administered IV and SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mirikizumab
Administered IV and SC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
* Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
* Participants must have evidence of UC extending proximal to the rectum
* Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC
Exclusion Criteria
* Participants must not have had surgery to remove part of their colon
* Participants must not have current evidence of toxic megacolon
* Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy
* Participants must not have had an inadequate response to Interleukin-12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
2 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Childrens Hospital of Orange County
Orange, California, United States
UCSF Medical Center at Mission Bay
San Francisco, California, United States
Children's Hospital of Colorado
Denver, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
Riley Hospital for Children
Carmel, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
MGH for Children - Waltham
Waltham, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Goryeb Children's Hospital / Atlantic Health System
Morristown, New Jersey, United States
Icahn Sch of Med at Mt. Sinai
New York, New York, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
The Abbigail Wexner Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Cook Children's Hospital
Fort Worth, Texas, United States
Texas Childrens Hospital
Houston, Texas, United States
Pediatrics Specialists of Virginia
Fairfax, Virginia, United States
Children's Hospital of The King's Daughters Inc
Norfolk, Virginia, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Rambam Medical Center
Haifa, , Israel
The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center
Jerusalem, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Kurume University Hospital
Kurume, Fukuoka, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan
Saitama Children's Medical Center
Saitama-shi, Saitama, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Medical and Dental University Hospital
Bunkyō, Tokyo, Japan
National Center For Child Health And Development
Setagaya-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Kyungpook National University Medical Center Chilgok Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I6T-MC-AMBU
Identifier Type: OTHER
Identifier Source: secondary_id
2019-001298-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17410
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.