Crohn's Disease
Mirikizumab for Children and Adolescents With Crohn’s Disease
This Phase 3 study is evaluating mirikizumab’s efficacy, safety, tolerability, and absorption in children and adolescents ages 2–17 with moderately to severely active Crohn’s disease.
Registry title: A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
15 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Mirikizumab
- Design
- Non Randomized
- Central study contact
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559LillyTrials@Lilly.com
- Sponsor
- Eli Lilly and Company
Research question
How effective, safe, and tolerable is mirikizumab, and how is it absorbed in children and adolescents with Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for children and adolescents ages 2 through 17.
- The study is looking for participants with Crohn’s disease or fistulizing Crohn’s disease involving active colitis, ileitis, or ileocolitis.
- The study is looking for moderately to severely active disease, defined by a baseline Pediatric Crohn’s Disease Activity Index score of at least 30.
- The study is looking for endoscopic evidence of active Crohn’s disease within one month before study treatment begins.
- The study is looking for participants with an inadequate response, loss of response, or intolerance to at least one Crohn’s disease medication.
Participation overview
What participation may involve
Participants are screened through the MACARONI-23 platform and may enter this mirikizumab-specific study arm. Mirikizumab is given intravenously or subcutaneously in weight-based dose groups. What participation may involve: - Screening takes place through the MACARONI-23 platform study. - Participants assigned to this intervention-specific arm receive mirikizumab intravenously or subcutaneously. - The study includes a 12-week induction period, maintenance from Week 12 through Week 52, and safety follow-up lasting up to 16 weeks. - Researchers assess Crohn’s disease activity, endoscopic findings, inflammation markers, and how mirikizumab moves through the body. The registry states that participation lasts about 74 weeks. The registry states that participation may include up to 19 visits.
Study interventions
What participants may receive or do
- Mirikizumab: Participants in the listed experimental groups receive mirikizumab intravenously or by a subcutaneous injection, with the dose group based on body weight.
Study design
How the comparison works
This is an open-label, Phase 3 interventional study with parallel mirikizumab dose groups based on weight. The registry contains conflicting information about whether assignment is randomized. The brief summary and official title describe random assignment, but the structured allocation field says non-randomized; the detailed description also says platform participants could be randomized to mirikizumab. The study is open-label, meaning the structured design reports no masking. The brief summary mentions assignment to mirikizumab or another intervention in the platform study, but this record lists only experimental mirikizumab dose groups and does not identify a comparator arm.
Reported activities
Procedures and tests
- Screening through the MACARONI-23 platform study.
- Intravenous infusions or subcutaneous injections of mirikizumab.
- Body-weight assessments used to select the appropriate mirikizumab dose group.
- Crohn’s disease activity assessments using the Pediatric Crohn’s Disease Activity Index and, for participants age 12 or older, the Crohn’s Disease Activity Index.
- Endoscopic assessment using the Simple Endoscopic Score for Crohn’s Disease.
- C-reactive protein measurements at baseline, Week 12, and Week 52.
- Fecal calprotectin measurements at baseline, Week 12, and Week 52.
- Pharmacokinetic assessments of mirikizumab clearance and volume of distribution through Week 52.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- A diagnosis of Crohn’s disease or fistulizing Crohn’s disease with active colitis, ileitis, or ileocolitis must have been confirmed by clinical, endoscopic, and histologic criteria.
- Crohn’s disease must be moderately to severely active, defined as a baseline Pediatric Crohn’s Disease Activity Index score of at least 30.
- An endoscopy within one month before study treatment at Week 0 must show active disease, with a Simple Endoscopic Score for Crohn’s Disease of at least 6, or at least 4 for isolated ileal disease.
- There must be a documented inadequate response, loss of response, or intolerance to at least one Crohn’s disease medication, such as an immunomodulator, corticosteroid, biologic therapy, or JAK inhibitor.
- Participants must be 2 through 17 years old.
Possible reasons someone may not be able to join
- Participants cannot have symptomatic strictures or stenosis, short gut syndrome, or another Crohn’s disease manifestation expected to require surgery.
- Participants cannot have an abscess.
- Participants cannot have had a bowel resection within 26 weeks before baseline or another intra-abdominal operation within 12 weeks before baseline.
Important unknowns
What the record does not make clear
- The registry reports up to 19 visits but does not give the timing, length, or activities for each visit.
- The record does not explain which existing Crohn’s disease treatments may continue during the study.
- The record does not state whether any medications must be stopped before mirikizumab begins or how long any washout would last.
- The record does not describe rescue treatment if Crohn’s disease worsens during the study.
- An endoscopy showing active disease is required within one month before Week 0, and Week 52 endoscopic outcomes are measured, but the record does not clearly describe who performs each endoscopy or the full procedure schedule.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not state whether participants or families receive compensation.
- The record does not state whether transportation, lodging, meals, or other travel expenses are supported.
- The record does not describe whether mirikizumab may remain available after study participation ends.
- The study is recruiting overall, but listed locations have recruiting, not-yet-recruiting, and terminated statuses.
- The official title and narrative describe random assignment, while the structured allocation field says non-randomized and the record lists only mirikizumab dose groups.
Before contacting the site
Questions for the study team
- How does assignment through the MACARONI-23 platform work, and could a participant receive an intervention other than mirikizumab?
- What happens at each of the possible 19 visits, and which visits require an infusion, injection, endoscopy, laboratory testing, or stool collection?
- Which current Crohn’s disease medicines may continue, which must stop, and what washout periods apply?
- How many endoscopies are required, and can an endoscopy already completed in clinical care satisfy the screening requirement?
- What is the plan if Crohn’s disease worsens during induction or maintenance?
- Which study-related costs are covered, and are compensation or travel and lodging support available?
- Is the mirikizumab cohort currently recruiting at the specific site being considered?
Before changing care
Questions for your gastroenterologist
- Would stopping or changing any current Crohn’s disease treatment for screening or study participation create a clinical concern?
- How stable is the disease now, and what signs would make trial screening or participation medically inappropriate to pursue?
- What approved treatment alternatives should be considered alongside learning more about this study?
- How should the gastroenterology team and research team coordinate endoscopies, laboratory monitoring, medication changes, and care if symptoms worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.
Study design and administration
- Organization
- Eli Lilly and Company
- Organization class
- Industry
- Organization study ID
- 16632
- Lead sponsor
- Eli Lilly and Company
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child
Study arms
Experimental
Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).
Interventions: Drug: Mirikizumab
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.
Interventions: Drug: Mirikizumab
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.
Interventions: Drug: Mirikizumab
Interventions
Drug
Mirikizumab
Administered IV or SC
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (4)
- 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.Registry-derived · unreviewed
- Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (3)
- 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.Registry-derived · unreviewed
- Participants must not have an abscess.Registry-derived · unreviewed
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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
Time frame: Baseline to Week 52
Clinical response based on PCDAI, and endoscopic response based on SES-CD.
Primary outcome
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
Time frame: Baseline to Week 52
Clinical response based on PCDAI, and clinical remission based on PCDAI.
Secondary outcome
Percentage of Participants Achieving Clinical Response by PCDAI
Time frame: Week 12
Clinical response based on PCDAI.
Secondary outcome
Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)
Time frame: Week 12
Clinical response based on CDAI for participants ≥12 years of age
Secondary outcome
Percentage of Participants Achieving Clinical Remission by PCDAI
Time frame: Week 12
Clinical remission based on PCDAI.
Secondary outcome
Percentage of Participants Achieving Clinical Remission by CDAI
Time frame: Week 12
Clinical remission based on CDAI for participants ≥12 years of age.
Secondary outcome
Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52
Time frame: Baseline to Week 52
Secondary outcome
Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52
Time frame: Week 52
Secondary outcome
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52
Time frame: Baseline to Week 52
Secondary outcome
Change from Baseline in C-reactive Protein (CRP)
Time frame: Baseline, Week 12
Secondary outcome
Change from Baseline in CRP
Time frame: Baseline, Week 52
Secondary outcome
Change from Baseline in Fecal calprotectin
Time frame: Baseline, Week 12
Secondary outcome
Change from Baseline in Fecal calprotectin
Time frame: Baseline, Week 52
Secondary outcome
Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52
Time frame: Baseline to Week 52
Clinical response by PCDAI, CDAI for participants ≥12 years of age
Secondary outcome
Percentage of Participants Achieving Endoscopic Response
Time frame: Week 52
Secondary outcome
Percentage of Participants Achieving Clinical Remission by PCDAI
Time frame: Week 52
Clinical remission based on PCDAI
Secondary outcome
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
Time frame: Baseline to Week 52
Clinical response and clinical remission by PCDAI
Secondary outcome
Pharmacokinetics (PK): Clearance of Mirikizumab
Time frame: Baseline through Week 52
Secondary outcome
Pharmacokinetics (PK): Volume of Distribution of Mirikizumab
Time frame: Baseline through Week 52
Recruiting locations in the United States
Cedars Sinai Medical Center
Not Yet RecruitingLos Angeles, California, 90048, United States
David Ziring
Connecticut Children's Medical Center
RecruitingHartford, Connecticut, 06032, United States
Jeffrey Hyams
Children's Center for Digestive Health Care, LLC
RecruitingAtlanta, Georgia, 30342, United States
Jeffery Lewis
Riley Childrens Hospital
RecruitingIndianapolis, Indiana, 46202, United States
Steven Steiner
Boston Children's Hospital
Not Yet RecruitingBoston, Massachusetts, 02115, United States
Athos Bousvaros
Atlantic Children's Health--Pediatric Gastroenterology
Not Yet RecruitingMorristown, New Jersey, 07960, United States
Oren Koslowe
Columbia University Medical Center/New York Presbyterian
RecruitingNew York, New York, 10032, United States
Joseph Picoraro
Icahn School of Medicine at Mount Sinai
RecruitingNew York, New York, 10029, United States
David Dunkin
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
RecruitingNew York, New York, 10021-5663, United States
Aliza Solomon
Children's Hospital of Philadelphia
RecruitingPhiladelphia, Pennsylvania, 19146, United States
Arthur Kastl
Cook Children's Medical Center
RecruitingFort Worth, Texas, 76104, United States
Clifton Huang
University of Vermont Medical Center
RecruitingBurlington, Vermont, 05401, United States
Jillian Sullivan
Seattle Children's Hospital
Not Yet RecruitingSeattle, Washington, 98105, United States
Ghassan Wahbeh
This study also lists 66 locations outside the United States. They are not shown here.
Central study contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
Physicians interested in becoming principal investigators please contact
Contact
Registry dates
- First posted
- Aug 22, 2022
- Primary completion
- Dec 2027
- Overall completion
- Apr 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.