A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Part of paid clinical trials in San Francisco, California.

Sponsor
Eli Lilly and Company
Study ID
NCT04844606
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirikizumab — DRUG
    Administered SC
  • Mirikizumab — DRUG
    Administered IV

Study Details

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

Key Dates

Start date
May 26, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Mirikizumab Dose 1 for UC
    Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
  • Experimental: Mirikizumab Dose 2 for UC
    Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Experimental: Mirikizumab Dose 3 for UC
    Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Experimental: Mirikizumab Dose 4 for CD
    Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Experimental: Mirikizumab Dose 5 for CD
    Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Experimental: Mirikizumab Dose 6 for CD
    Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
  • Experimental: Mirikizumab Dose 7 for UC or CD
    Intravenous (IV) rescue dosing, if response is lost.

Primary Outcome Measure

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission [ Time Frame: 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 (11)

FacilityCityStateZIPSite coordinators
UCSF Medical Center at Mission BaySan FranciscoCalifornia94158
Sofia Verstraete (PRINCIPAL_INVESTIGATOR)
Connecticut Children's Medical CenterHartfordConnecticut06106
Jeffrey Hyams (PRINCIPAL_INVESTIGATOR)
Children's Center for Digestive Health Care, LLCAtlantaGeorgia30342
Jeffery Lewis (PRINCIPAL_INVESTIGATOR)
Emory University School of MedicineAtlantaGeorgia30322
subra kugathasan (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBostonMassachusetts02115
617-355-6058
Athos Bousvaros (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalWalthamMassachusetts02451
Jess Kaplan (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
314-454-6173
Charles Samson (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
212-241-5415
David Dunkin (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104
Arthur Kastl (PRINCIPAL_INVESTIGATOR)
Cook Children's Medical CenterFort WorthTexas76104
682-885-1990
Clifton Huang (PRINCIPAL_INVESTIGATOR)
Pediatric Specialists of VirginiaFairfaxVirginia22031
703-876-2788
Peter Lee (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
UCSF Medical Center at Mission Bay· San Francisco, CAConnecticut Children's Medical Center· Hartford, CTChildren's Center for Digestive Health Care, LLC· Atlanta, GAEmory University School of Medicine· Atlanta, GABoston Children's Hospital· Boston, MAMassachusetts General Hospital· Waltham, MA

Related Studies