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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05784246




Registration number
NCT05784246
Ethics application status
Date submitted
13/03/2023
Date registered
24/03/2023

Titles & IDs
Public title
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
I6T-MC-AMBA
Secondary ID [2] 0 0
16634
Universal Trial Number (UTN)
Trial acronym
SHINE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirikizumab IV
Treatment: Drugs - Mirikizumab SC

Experimental: Mirikizumab Weight-Based Group 1 - Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).

Experimental: Mirikizumab Weight-Based Group 2 - Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.

Experimental: Mirikizumab Weight-Based Group 3 - Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.


Treatment: Drugs: Mirikizumab IV
Administered IV

Treatment: Drugs: Mirikizumab SC
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Percentage of Participants in MMS Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants in MMS Clinical Response
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants with Endoscopic Remission
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants with Endoscopic Improvement
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving PUCAI Clinical Remission
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Percentage of Participants Achieving MMS Clinical Response
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Percentage of Participants Achieving MMS Clinical Remission
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Percentage of Participants Achieving PUCAI Clinical Response
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Percentage of Participants Achieving PUCAI Clinical Remission
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Percentage of Participants Achieving Endoscopic Remission
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Percentage of Participants Achieving Endoscopic Improvement
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids
Timepoint [14] 0 0
Baseline to Week 52
Secondary outcome [15] 0 0
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
Timepoint [16] 0 0
Baseline to Week 52
Secondary outcome [17] 0 0
PK: Cmax of Mirikizumab
Timepoint [17] 0 0
Baseline to Week 52

Eligibility
Key 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.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [2] 0 0
Women'S and Children'S Hospital, Adelaide - North Adelaide
Recruitment hospital [3] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Canada
State/province [12] 0 0
British Colombia
Country [13] 0 0
Canada
State/province [13] 0 0
Nova Scotia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
France
State/province [15] 0 0
Rhone
Country [16] 0 0
France
State/province [16] 0 0
Somme
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Germany
State/province [18] 0 0
Bayern
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein Westfalen
Country [20] 0 0
Germany
State/province [20] 0 0
Rheinland Pfalz
Country [21] 0 0
Israel
State/province [21] 0 0
Yerushalayim
Country [22] 0 0
Israel
State/province [22] 0 0
Haifa
Country [23] 0 0
Israel
State/province [23] 0 0
Jerusalem
Country [24] 0 0
Israel
State/province [24] 0 0
Petach-Tikva
Country [25] 0 0
Israel
State/province [25] 0 0
Zerifin
Country [26] 0 0
Italy
State/province [26] 0 0
Firenze
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba-Ken
Country [29] 0 0
Japan
State/province [29] 0 0
Kanagawa
Country [30] 0 0
Japan
State/province [30] 0 0
Mie-Ken
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Japan
State/province [32] 0 0
Saga
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Korea
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Kwangyokshi
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul-teukbyeolsi [Seoul]
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Busan
Country [37] 0 0
Korea, Republic of
State/province [37] 0 0
Seoul
Country [38] 0 0
Netherlands
State/province [38] 0 0
Amsterdam
Country [39] 0 0
Netherlands
State/province [39] 0 0
Rotterdam
Country [40] 0 0
Poland
State/province [40] 0 0
Krakow
Country [41] 0 0
Poland
State/province [41] 0 0
Rzeszow
Country [42] 0 0
Poland
State/province [42] 0 0
Szczecin
Country [43] 0 0
Poland
State/province [43] 0 0
Warszawa
Country [44] 0 0
Poland
State/province [44] 0 0
Wroclaw
Country [45] 0 0
Portugal
State/province [45] 0 0
Braga
Country [46] 0 0
Portugal
State/province [46] 0 0
Porto
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London, City Of
Country [48] 0 0
United Kingdom
State/province [48] 0 0
South Yorkshire
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05784246