Clinical trial NCT05784246: A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Official title: A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Percentage of Participants in MMS Clinical Remission
timeFrame: Week 12
measure: Percentage of Participants in MMS Clinical Response
timeFrame: Week 12
measure: Percentage of Participants with Endoscopic Remission
timeFrame: Week 12
measure: Percentage of Participants with Endoscopic Improvement
timeFrame: Week 12
measure: Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
timeFrame: Week 12
measure: Percentage of Participants Achieving PUCAI Clinical Remission
timeFrame: Week 12
measure: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
timeFrame: Week 12
measure: Percentage of Participants Achieving MMS Clinical Response
timeFrame: Week 52
measure: Percentage of Participants Achieving MMS Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants Achieving PUCAI Clinical Response
timeFrame: Week 52
measure: Percentage of Participants Achieving PUCAI Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants Achieving Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants Achieving Endoscopic Improvement
timeFrame: Week 52
measure: Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids
timeFrame: Baseline to Week 52
measure: Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
timeFrame: Week 52
measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
timeFrame: Baseline to Week 52
measure: PK: Cmax of Mirikizumab
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital- San Diego
state: California
city: San Francisco
country: United States
facility: University of California-San Francisco-Mission Bay
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: GI Care for Kids
state: Georgia
city: Indianapolis
country: United States
facility: Riley Childrens Hospital
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital for Children
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Greenville
country: United States
facility: Pediatric Gastroenterology Prisma Health - Upstate
state: South Carolina
city: Edegem
country: Belgium
facility: UZA
city: Leuven
country: Belgium
facility: UZ Leuven
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre (LHSC) - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Amiens
country: France
facility: CHU Amiens - Picardie Site Sud
state: Somme
city: Bron
country: France
facility: Groupement Hospitalier Est
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Hôpital Necker - Enfants Malades
city: Muenchen
country: Germany
facility: LMU-Campus Innenstadt
state: Bayern
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
state: Nordrhein Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
state: Rheinland Pfalz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Mount Scopus
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Zerifin
country: Israel
facility: Shamir Medical Center
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Kashiwa-shi
country: Japan
facility: Kokikai Tsujinaka Hospital Kashiwanoha
state: Chiba-Ken
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center, Center of IBD
state: Kanagawa-Ken
city: Tsu-Shi
country: Japan
facility: Mie University Hospital
state: Mie-Ken
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Saga
country: Japan
facility: Saga University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Medical Center Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
city: Warszawa
country: Poland
facility: Warsaw IBD Point Profesor Kierkus
city: Warszaw
country: Poland
facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Braga
country: Portugal
facility: Hospital de Braga
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, E.P.E.
city: London
country: United Kingdom
facility: King's College Hospital
state: Greater London
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
state: South Yorkshire
city: London
country: United Kingdom
facility: Children's Clinical Research Facility
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: