Recruiting
Phase 3

Mirikizumab

Sponsor:

Eli Lilly and Company

Code:

NCT05509777

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Mirikizumab

Study Details

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.

Conditions

Crohn's Disease

Study ID

NCT05509777

Start date

Mar 13, 2024

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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.

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

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Mirikizumab

Administered IV or SC

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06032

Contacts

860-837-5591

Principal Investigator:

Jeffrey Hyams

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

404-727-4542

Principal Investigator:

subra kugathasan

Children's Center for Digestive Health Care, LLC

Recruiting

Atlanta, Georgia, United States, 30342

Principal Investigator:

Jeffery Lewis

Riley Childrens Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

317-274-5858

Principal Investigator:

Steven Steiner

Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

Recruiting

New York, New York, United States, 10021-5663

Contacts

646-962-7162

Principal Investigator:

Aliza Solomon

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

212-659-9443

Principal Investigator:

David Dunkin

Columbia University Medical Center/New York Presbyterian

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Joseph Picoraro

Childrens Medical Center

Recruiting

Dayton, Ohio, United States, 45404

Contacts

937-641-5605

Principal Investigator:

Shehzad Saeed

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

973-971-7747

Principal Investigator:

Arthur Kastl

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Principal Investigator:

Clifton Huang

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

802-656-9402

Principal Investigator:

Jillian Sullivan

IWK Health Centre

Recruiting

Halifax, Canada, B3K 6R8

Contacts

1-902-470-7009

Principal Investigator:

Anthony Otley

London Health Sciences Centre (LHSC) - Victoria Hospital

Recruiting

London, Canada, N6A 5W9

Contacts

519-685-8500 x56074

Principal Investigator:

Dhandapani Ashok

The Hospital for Sick Children

Recruiting

Toronto, Canada, M5G 1X8

Principal Investigator:

Thomas Walters

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Inflammatory Bowel Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.