Clinical Trial Search

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

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

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

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

Primary: Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks — 23; 12 participants — p=.005

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

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

Primary: Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) — 10; 7; 9; 6 Participants

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

Primary: Percentage of Participants in Clinical Remission at Week 12 — 2.7; 11.3; 16.7; 15.5 percentage of participants — p=0.0213

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

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

Primary: Number of Relapses by Group — 0; 3 relapses — p=0.046

Primary: Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events — 33; 3; 8; 1 Participants

Primary: Percentage of Patients Who Achieved Clinical Response — 57; 35 percentage of patients — p=0.05

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: Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to…

Primary: Incidence of Treatment Emergent AEs — 273 participants

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

Primary: Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score at Day 57 — 63.6; 54.5; 54.5 Percentage of participants — p=1.0000

Primary: Change From Baseline in Total MCS at Week 6 — -2.6; -2.6 units on a scale — p=0.981

Primary: Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 — 9.2; 10.0; 18.5 Proportion of participants — p=0.031

Primary: Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54 — 24.9 Percentage of Participants

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

Primary: Part A: Number of Participants With Common (>=5%) Non-serious Adverse Events (Non-SAEs) and Any Serious Adverse Events (SAEs) — 7; 13; 1; 0 Participants