Clinical trial NCT04844606: A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Official title: A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic
Inflammatory Bowel Diseases
Crohn's Disease
Keywords: Pediatric Ulcerative Colitis
Pediatric Crohn's Disease
Pediatric UC
Pediatric CD
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.


Eligibility criteria: Inclusion Criteria:

* Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
* Female participants must agree to contraception requirements.

Exclusion Criteria:

* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
* Participants must not have adenomatous polyps that have not been removed.
* Participants must not be pregnant or breastfeeding.

Primary outcomes:
measure: Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants with UC in MMS Clinical Response
timeFrame: Week 52
measure: Percentage of Participants with CD in PCDAI Clinical Response
timeFrame: Week 52
measure: Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
timeFrame: Week 52
measure: Percentage of Participants with UC in PUCAI Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants with UC in Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants with CD in Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants with UC in Endoscopic Response
timeFrame: Week 52
measure: Percentage of Participants with CD in Endoscopic Response
timeFrame: Week 52
measure: Percentage of Participants with UC in having Endoscopic Subscore = 0
timeFrame: Week 52
measure: Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission
timeFrame: Week 52
measure: Percentage of Participants with CD Achieving Histologic Response
timeFrame: Week 52
measure: Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery
timeFrame: Week 52
measure: Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery
timeFrame: Week 52
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Mission Bay
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Children's Center for Digestive Health Care, LLC
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Fairfax
country: United States
facility: Pediatric Specialists of Virginia
state: Virginia
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
city: Brussels
country: Belgium
facility: UZ Brussel
state: Bruxelles-Capitale, Région De
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Vitoria
country: Brazil
facility: Hospital Universitario Cassiano Antonio de Moraes
state: Espírito Santo
city: Goiania
country: Brazil
facility: Universidade Federal de Goias
state: Goiás
city: Curitiba
country: Brazil
facility: Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Votuporanga
country: Brazil
facility: Integral Pesquisa e Ensino
state: São Paulo
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
state: Nord-Pas-de-Calais
city: Amiens
country: France
facility: CHU d'Amiens-Picardie - Hôpital Sud
state: Somme
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Hôpital Universitaire Necker Enfants Malades
city: Munich
country: Germany
facility: Dr. von Haunersches Kinderspital
state: Bayern
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz
state: Rheinland-Pfalz
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
state: HaMerkaz
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
state: Lazio
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
state: Lombardia
city: Milan
country: Italy
facility: Ospedale dei Bambini Vittore Buzzi
state: Milano
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesù IRCCS
state: Roma
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Meyer IRCCS
state: Toscana
city: Bologna
country: Italy
facility: Ospedale Maggiore Azienda USL di Bologna
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital - Kashiwanoha
state: Chiba
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyō
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
state: Taegu-Kwangyǒkshi
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
state: Zuid-Holland
city: Warsaw
country: Poland
facility: Centrum Zdrowia Dziecka w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
state: Mazowieckie
city: Rzeszów
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
state: Podkarpackie
city: Szczecin
country: Poland
facility: Twoja Przychodnia SCM
state: Zachodniopomorskie
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona [Barcelona]
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Oxford
country: United Kingdom
facility: The John Radcliffe Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
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 - hours, EST)
role: STUDY_DIRECTOR
References: