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

Conditions

• Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

15 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Mirikizumab — DRUG
  Administered IV
• Mirikizumab — DRUG
  Administered SC
• Ustekinumab — DRUG
  Administered IV
• Ustekinumab — DRUG
  Administered SC
• Placebo — DRUG
  Administered IV
• Placebo — DRUG
  Administered SC

Study Details

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Key Dates

Start date

Jul 23, 2019

Status verified

Dec 2024

Primary completion

Aug 23, 2023

Completion

Oct 2, 2023

Study Design

Enrollment

1,158 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.
• Experimental: 300 mg Mirikizumab
  Participants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
• Active Comparator: 90 mg Ustekinumab
  Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)
• Experimental: 300 mg Mirikizumab (Adolescents)
  Participants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W

Primary Outcome Measure

Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) [ Time Frame: Week 12 to Week 52 ]

Locations (140)

Find similar trials in Birmingham, AL

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