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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

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 (=) 9 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 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 SES-CD score =6 (or =4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
* 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
1/04/2028
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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United States of America
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Connecticut
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United States of America
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Georgia
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United States of America
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Indiana
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United States of America
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Massachusetts
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New Jersey
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New York
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Ohio
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Pennsylvania
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Texas
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Vermont
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Washington
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Austria
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Vienna
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Belgium
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Brussel
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Belgium
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Vlaams-Brabant
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Belgium
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Gent
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Rio Grande Do Sul
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Sao Paulo
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Brazil
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São Paulo
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Brazil
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Curitiba-PR
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Brazil
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Goiânia
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Brazil
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Santos Dumont
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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France
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Amiens
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France
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Paris
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Israel
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Israel
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Israel
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Israel
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Jerusalem
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Israel
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Petah Tiqva
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Bergamo
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Italy
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Bologna
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Firenze
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Italy
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Milano
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Italy
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Roma
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Japan
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Aomori Pref.
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Japan
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Chiba-Ken
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Hyogo
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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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Korea, Republic of
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Gyeongsangbuk-do
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Korea
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Korea, Republic of
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Kwangyokshi
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Teukbyeolsi [Seoul]
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Korea, Republic of
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Seoul
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Netherlands
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Zuid-Holland
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Nordbyagen
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Oslo
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Tromsø
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Trondheim
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Masovian
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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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Portugal
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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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Spain
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València
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United Kingdom
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Greater London
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United Kingdom
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London, City Of
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United Kingdom
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Lothian Region
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Oxford
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United Kingdom
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South Yorkshire
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United Kingdom
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Manchester

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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT05509777