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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05784246
Other study ID # 16634
Secondary ID I6T-MC-AMBA2022-
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 22, 2023
Est. completion date March 31, 2027

Study information

Verified date June 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 1-317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 31, 2027
Est. primary completion date July 20, 2026
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility Inclusion Criteria: - Males or females weighing >10 kg and =2 and <18 years old - Have moderate to severe UC - Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mirikizumab IV
Administered IV
Mirikizumab SC
Administered SC

Locations

Country Name City State
Australia Perth Children's Hospital Nedlands Western Australia
Australia Women'S and Children'S Hospital, Adelaide North Adelaide South Australia
Australia Mater Hospital Brisbane South Brisbane Queensland
Belgium UZA Edegem
Belgium UZ Leuven Leuven
Canada 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 Children's & Women's Health Centre of British Columbia Vancouver British Colombia
France CHU Amiens - Picardie Site Sud Amiens Somme
France Groupement Hospitalier Est Bron Rhone
France Hôpital Armand Trousseau Paris
France Hôpital Necker - Enfants Malades Paris
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Rheinland Pfalz
Germany LMU-Campus Innenstadt Muenchen Bayern
Germany Helios Klinikum Wuppertal Wuppertal Nordrhein Westfalen
Israel Rambam Health Care Campus Haifa
Israel Hadassah University Hospital - Mount Scopus Jerusalem Yerushalayim
Israel Shaare Zedek Medical Center Jerusalem
Israel Schneider Children's Medical Center Petach-Tikva
Israel Shamir Medical Center Zerifin
Italy 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
Japan Tokyo Medical and Dental University Hospital Bunkyo Tokyo
Japan Juntendo University Hospital Bunkyo-ku Tokyo
Japan Kokikai Tsujinaka Hospital Kashiwanoha Kashiwa-shi Chiba-Ken
Japan Saga University Hospital Saga
Japan National Center for Child Health and Development Setagaya-ku Tokyo
Japan Mie University Hospital Tsu-Shi Mie-Ken
Japan Yokohama City University Medical Center, Center of IBD Yokohama Kanagawa
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Kyungpook National University Medical Center Chilgok Hospital Daegu Kwangyokshi
Korea, Republic of Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Korea
Netherlands Amsterdam UMC, locatie AMC Amsterdam
Netherlands Erasmus Medisch Centrum Rotterdam
Poland Uniwersytecki Szpital Dzieciecy w Krakowie Krakow
Poland Korczowski Bartosz, Gabinet Lekarski Rzeszow
Poland Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Szczecin
Poland Instytut "Pomnik - Centrum Zdrowia Dziecka" Warszawa
Poland Warsaw IBD Point Profesor Kierkus Warszawa
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar de São João, E.P.E. Porto
United Kingdom King's College Hospital London Greater London
United Kingdom Sheffield Children's Hospital Sheffield South Yorkshire
United Kingdom Children's Clinical Research Facility Whitechapel Greater London
United States Children's Center for Digestive Health Care, LLC Atlanta Georgia
United States Boston Children's Hospital Boston Massachusetts
United States Massachusetts General Hospital for Children Boston Massachusetts
United States Cincinnati Childrens Hospital Medical Center Cincinnati Ohio
United States Connecticut Children's Medical Center Hartford Connecticut
United States Riley Childrens Hospital Indianapolis Indiana
United States Children's Hospital Los Angeles Los Angeles California
United States Morristown Medical Center Morristown New Jersey
United States Icahn School of Medicine at Mount Sinai New York New York
United States St. Louis Children's Hospital Saint Louis Missouri
United States Rady Children's Hospital- San Diego San Diego California
United States University of California-San Francisco-Mission Bay San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders Baseline to Week 52
Secondary Percentage of Participants in MMS Clinical Remission Week 12
Secondary Percentage of Participants in MMS Clinical Response Week 12
Secondary Percentage of Participants with Endoscopic Remission Week 12
Secondary Percentage of Participants with Endoscopic Improvement Week 12
Secondary Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response Week 12
Secondary Percentage of Participants Achieving PUCAI Clinical Remission Week 12
Secondary Percentage of Participants in Histologic Endoscopic Mucosal Remission Week 12
Secondary Percentage of Participants Achieving MMS Clinical Response Week 52
Secondary Percentage of Participants Achieving MMS Clinical Remission Week 52
Secondary Percentage of Participants Achieving PUCAI Clinical Response Week 52
Secondary Percentage of Participants Achieving PUCAI Clinical Remission Week 52
Secondary Percentage of Participants Achieving Endoscopic Remission Week 52
Secondary Percentage of Participants Achieving Endoscopic Improvement Week 52
Secondary 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
Secondary Percentage of Participants in Histologic Endoscopic Mucosal Remission Week 52
Secondary Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab PK: AUC of Mirikizumab Baseline to Week 52
Secondary PK: Cmax of Mirikizumab Baseline to Week 52
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