Clinical Trial Search

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

Primary: Clinical Remission — 5; 2; 9; 4 Participants — p=0.1806

Primary: Percentage of Participants With Remission at Week 8 — 16.6; 3.6 percentage of participants — p=0.0005

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

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: Number of Subjects With Treatment-emergent Adverse Events — 18; 5 Participants — p=0.2096

Primary: Percentage of Participants Achieving Clinical Remission at Week 12 — 27.0; 7.4 Percentage of participants — p=<0.001

Primary: Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 — 11.6; 25.5; 23.3; 23.9 percentage of participants — p=0.0545

Primary: Percentage of Participants With Clinical Response — 47.5; 29.6; 51.6; 63.3 percentage of participants

Primary: Percentage of Participants With Remission at Week 8 — 18.5; 8.2 percentage of participants — p=0.0070

Primary: Relapse Free Survival Week 17-48 — 12; 12 Participants

Primary: Number of Subjects With Treatment-related Adverse Events — 5; 7; 7; 14 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: Reduction From Baseline in Modified Mayo Score (MMS) at Week 8 — -2.9; -3.2; -3.1; -1.9 Score

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

Primary: Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS) — 26.0; 18.3 Percentage of participants — p=0.2524

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

Primary: Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE) — 10; 7; 9; 6 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 Achieving Clinical Remission — 24.8; 15.2 Percentage of participants — p==0.026

Primary: Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS — 9; 17; 22 Participants

Primary: Percentage of Participants With Remission at Week 8 — 4.3; 0.0; 2.5; 13.3 percentage of participants — p=0.021

Primary: Percentage of Participants in Clinical Response at Week 12 — 53.8; 50.0 Percentage of participants

Primary: Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8 — 16.5; 9.3 Percentage of Participants — p=0.019

Primary: Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events (TEAEs) (SAD/MAD) — 0.0; 20.0; 20.0; 60.0 percentage 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: 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 With Clinical Remission at Week 12 — 13.3; 24.2 percentage of participants — p=0.00006