Clinical Trial Search

Primary: Percentage of Participants Achieving Endoscopic Improvement — 16.7 percentage of participants

Primary: Percentage of Participants With Active CD at Day 1 — 45.3 percentage of participants

Primary: Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories — 9.1; 3.4; 10.5; 13.0 Percentage of participants

Primary: Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score. — 7; 12 Participants — p=0.106

Primary: Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months — 83.7; 81.5 percent of participants

Primary: Change From Baseline for Adapted Mayo Score: 0.2 mg Versus Placebo — -2.60; -1.95 score on a scale

Primary: Induction Period: Percentage of Participants With Clinical Remission at Week 12 — 4.8; 15.9; 22.6; 11.5 percentage of participants

Primary: Percentage of Participants in Clinical Remission at 10 Weeks — 18.4; 6.0; 21.0 Percentage — p=0.0001

Primary: Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12 — 12.1; 31.6; 21.8 Percentage of Participants — p=0.0142

Primary: Percentage of Participants With Clinical Remission at Week 12 — 13.3; 24.2 percentage of participants — p=0.00006

Primary: Number of Subjects With Treatment-related Adverse Events — 5; 7; 7; 14 Participants

Primary: Number of Participants With a Clinical Response at Week 8 — 33; 45; 30 Participants

Primary: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) — 30; 26; 14; 41 participants — p=0.124

Primary: Number of Participants Who Experienced an Adverse Event (AE) — 7; 10; 18; 10 Participants

Primary: Number of Participants With Clinical Response at Week 6 — 76; 129; 141 Participants — p=<0.0001

Primary: Percentage of Patients Achieving Clinical Remission at Week 54 — 127; 30 Participants — p=<0.0001

Primary: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) — 31.4; 24.1; 44.4; 30.0 percentage of participants

Primary: Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Score (MMS) at Week 8 — 17.1 percentage of participants

Primary: The Level of Immunoglobulin (Ig) A — 270.42; 208.63 mg/dL

Primary: Clinical Response — 5; 2; 1 Participants

Primary: Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment — 20.72; 20.45; 23.05; 22.65 hours

Primary: Number of Participants With Clinical Toxicity Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version (v.) 4.0 — 2; 0…

Primary: Number of Patients Who Experienced Improvement of Pouchitis Symptoms — 2 Participants

Primary: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 — 33.5; 4.1 percentage of participants — p=<0.001

Primary: Incidence of Treatment Emergent AEs — 273 participants

Primary: Clinical Remission Response Rate at Week 12 — 14.8; 16.3 Percentage of Participants — p=0.5935

Primary: Percentage of Participants With a Clinical Response — 53; 44 percentage of participants

Primary: Pharmacokinetics (PK): Clearance of Mirikizumab — 0.000190 Liters per hour per kilogram (L/hr/kg)

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 154; 626; 39; 147 Participants

Primary: Percentage of Participants With Clinical Remission at Week 8 — 5; 4; 5; 11 Participants