A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
- Registration Number
- NCT05784246
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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).
- Detailed Description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mirikizumab Weight-Based Group 3 Mirikizumab IV Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. Mirikizumab Weight-Based Group 1 Mirikizumab IV Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). Mirikizumab Weight-Based Group 1 Mirikizumab SC Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). Mirikizumab Weight-Based Group 3 Mirikizumab SC Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. Mirikizumab Weight-Based Group 2 Mirikizumab IV Experimental: Participants will receive mirikizumab weight-based dosing IV or SC. Mirikizumab Weight-Based Group 2 Mirikizumab SC Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders Baseline to Week 52
- Secondary Outcome Measures
Name Time Method Percentage of Participants in MMS Clinical Remission Week 12 Percentage of Participants in MMS Clinical Response Week 12 Percentage of Participants with Endoscopic Remission Week 12 Percentage of Participants with Endoscopic Improvement Week 12 Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response Week 12 Percentage of Participants Achieving PUCAI Clinical Remission Week 52 Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement Week 52 Percentage of Participants Achieving MMS Clinical Response Week 52 Percentage of Participants Achieving MMS Clinical Remission Week 52 Percentage of Participants Achieving PUCAI Clinical Response Week 52 Percentage of Participants Achieving Endoscopic Remission Week 52 Percentage of Participants Achieving Endoscopic Improvement Week 52 Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids Baseline to Week 52 Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab Baseline to Week 52 PK: AUC of Mirikizumab
PK: Cmax of Mirikizumab Baseline to Week 52
Trial Locations
- Locations (56)
Rady Children's Hospital- San Diego
🇺🇸San Diego, California, United States
University of California-San Francisco-Mission Bay
🇺🇸San Francisco, California, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
GI Care for Kids
🇺🇸Atlanta, Georgia, United States
Riley Childrens Hospital
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital for Children
🇺🇸Boston, Massachusetts, United States
Hadassah University Hospital - Mount Scopus
🇮🇱Jerusalem, Israel
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Pediatric Gastroenterology Prisma Health - Upstate
🇺🇸Greenville, South Carolina, United States
UZA
🇧🇪Edegem, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
🇨🇦London, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
CHU Amiens - Picardie Site Sud
🇫🇷Amiens, Somme, France
Groupement Hospitalier Est
🇫🇷Bron, France
Hôpital Armand Trousseau
🇫🇷Paris, France
Hôpital Necker - Enfants Malades
🇫🇷Paris, France
LMU-Campus Innenstadt
🇩🇪Muenchen, Bayern, Germany
Helios Klinikum Wuppertal
🇩🇪Wuppertal, Nordrhein Westfalen, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Rheinland Pfalz, Germany
Rambam Health Care Campus
🇮🇱Haifa, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Schneider Children's Medical Center
🇮🇱Petach-Tikva, Israel
Shamir Medical Center
🇮🇱Zerifin, Israel
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
🇮🇹Firenze, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
🇮🇹Roma, Italy
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Italy
Kokikai Tsujinaka Hospital Kashiwanoha
🇯🇵Kashiwa-shi, Chiba-Ken, Japan
Yokohama City University Medical Center, Center of IBD
🇯🇵Yokohama-shi, Kanagawa-Ken, Japan
Mie University Hospital
🇯🇵Tsu-Shi, Mie-Ken, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Center for Child Health and Development
🇯🇵Setagaya-ku, Tokyo, Japan
Saga University Hospital
🇯🇵Saga, Japan
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyungpook National University Medical Center Chilgok Hospital
🇰🇷Deagu, Taegu-Kwangyǒkshi, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Amsterdam UMC, locatie AMC
🇳🇱Amsterdam, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszow, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
🇵🇱Szczecin, Poland
Warsaw IBD Point Profesor Kierkus
🇵🇱Warszawa, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
🇵🇱Warszaw, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Centro Hospitalar de São João, E.P.E.
🇵🇹Porto, Portugal
King's College Hospital
🇬🇧London, Greater London, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, South Yorkshire, United Kingdom
Children's Clinical Research Facility
🇬🇧London, United Kingdom