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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05509777




Registration number
NCT05509777
Ethics application status
Date submitted
19/08/2022
Date registered
22/08/2022
Date last updated
18/06/2024

Titles & IDs
Public title
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Scientific title
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Secondary ID [1] 0 0
I6T-MC-AMAY
Secondary ID [2] 0 0
16632
Universal Trial Number (UTN)
Trial acronym
AMAY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

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

Experimental: Mirikizumab Dose 1 - Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).

Experimental: Mirikizumab Dose 2 - Mirikizumab administered IV or SC in participants that weigh \>20 kg to less than or equal to (=) 40 kg.

Dosing is based on assessments of the participant's weight and appropriate weight class.

Experimental: Mirikizumab Dose 3 - Mirikizumab administered IV or SC in participants that weigh greater than or equal to (=)10 kg to less than or equal to =20 kg.

Dosing is based on assessments of the participant's weight and appropriate weight class.


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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52
Timepoint [1] 0 0
Baseline to Week 52
Primary outcome [2] 0 0
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Response by PCDAI
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Clinical Remission by PCDAI
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants Achieving Clinical Remission by CDAI
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
Percentage of Participants Achieving Endoscopic Response by SES-CD
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52
Timepoint [6] 0 0
Baseline to Week 52
Secondary outcome [7] 0 0
Change from Baseline in C-reactive Protein (CRP)
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Change from Baseline in CRP
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Change from Baseline in Fecal calprotectin
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Change from Baseline in Fecal calprotectin
Timepoint [10] 0 0
Baseline, Week 52
Secondary outcome [11] 0 0
Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52
Timepoint [11] 0 0
Baseline to Week 52
Secondary outcome [12] 0 0
Percentage of Participants Achieving Endoscopic Response
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Percentage of Participants Achieving Clinical Remission by PCDAI
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and who did not have Crohn's disease (CD)-Related Surgery at Week 52
Timepoint [14] 0 0
Baseline to Week 52
Secondary outcome [15] 0 0
Pharmacokinetics (PK): Clearance of Mirikizumab
Timepoint [15] 0 0
Baseline through Week 52
Secondary outcome [16] 0 0
Pharmacokinetics (PK): Volume of Distribution of Mirikizumab
Timepoint [16] 0 0
Baseline through Week 52

Eligibility
Key inclusion criteria
* Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
* Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
* Participants must have endoscopy with evidence of active CD defined as as SES-CD score =6 (or =4 for participants with isolated ileal disease) during screening into this study.
* Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
* Participants must not have an abscess.
* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

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
13/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/10/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [3] 0 0
Women'S and Children'S Hospital, Adelaide - North Adelaide
Recruitment hospital [4] 0 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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California
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Connecticut
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Florida
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Georgia
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Indiana
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Massachusetts
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Vienna
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Brabant
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Brussels
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Nova Scotia
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Ontario
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Cedex1
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Bologna
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Firenze
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Roma
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Japan
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Aomori Pref.
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Chiba-Ken
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Japan
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Kanagawa-Ken
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Miyagi
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Tokyo
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Saga
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Krakow
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Rzeszow
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Warszawa
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Portugal
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Braga
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Lisboa
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Porto
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Spain
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Barcelona
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Spain
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Cordoba
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Esplugues de Llobregat
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Spain
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València
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United Kingdom
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Gb-oxf
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Greater London
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Greater Manchester
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Lothian Region
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South Yorkshire
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.

Study periods for the intervention-specific appendix (ISA) will be as follows:

* A 12-week induction period
* A maintenance period from Week 12 to Week 52, and
* A safety follow-up period up to 16 weeks.

The study will last about 74 weeks and may include up to 19 visits.
Trial website
https://clinicaltrials.gov/study/NCT05509777
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05509777