A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eli Lilly and Company
Study ID
NCT05509777
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirikizumab — DRUG
    Administered IV or SC

Study Details

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.

Key Dates

Start date
Mar 13, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (15)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
310-248-8516
David Ziring (PRINCIPAL_INVESTIGATOR)
Connecticut Children's Medical CenterHartfordConnecticut06032
860-837-5591
Jeffrey Hyams (PRINCIPAL_INVESTIGATOR)
Children's Center for Digestive Health Care, LLCAtlantaGeorgia30342
Jeffery Lewis (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
404-727-4542
subra kugathasan (PRINCIPAL_INVESTIGATOR)
Riley Childrens HospitalIndianapolisIndiana46202
317-274-5858
Steven Steiner (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
617-355-6058
Athos Bousvaros (PRINCIPAL_INVESTIGATOR)
Atlantic Children's Health--Pediatric GastroenterologyMorristownNew Jersey07960
973-971-6489
Oren Koslowe (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center/New York PresbyterianNew YorkNew York10032
Joseph Picoraro (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
212-659-9443
David Dunkin (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)New YorkNew York10021-5663
646-962-7162
Aliza Solomon (PRINCIPAL_INVESTIGATOR)
Childrens Medical CenterDaytonOhio45404
937-641-5605
Shehzad Saeed (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146
973-971-7747
Arthur Kastl (PRINCIPAL_INVESTIGATOR)
Cook Children's Medical CenterFort WorthTexas76104
Clifton Huang (PRINCIPAL_INVESTIGATOR)
University of Vermont Medical CenterBurlingtonVermont05401
802-656-9402
Jillian Sullivan (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
206-987-1293
Ghassan Wahbeh (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Cedars Sinai Medical Center· Los Angeles, CAConnecticut Children's Medical Center· Hartford, CTChildren's Center for Digestive Health Care, LLC· Atlanta, GAEmory University· Atlanta, GARiley Childrens Hospital· Indianapolis, INBoston Children's Hospital· Boston, MA

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