A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— SHINE-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: April 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
• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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
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	Royal London Hospital	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

External Links

•   A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)