Ulcerative Colitis, Crohn’s Disease
Conditions
Brief summary
Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values, Prospective Observer-Blinded Endpoint ISAs: CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase, Randomized Placebo-Controlled ISAs: Proportion of participants with clinical remission at end of Induction Phase
Detailed description
Proportion of participants with clinical remission at end of Induction Phase, CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase, Proportion of participants with Patient-Reported Outcome-2 (PRO-2) remission at end of Induction Phase, Proportion of participants with clinical response at end of Induction Phase, CD: Proportion of participants with endoscopic and clinical response at end of Induction Phase, UC: Proportion of participants with histologic response at end of Induction Phase, UC: Proportion of participants with histologic remission at end of Induction Phase, UC: Proportion of participants with histologic-endoscopic mucosal improvement at end of Induction Phase, CD: Change in SES-CD from Day 1 to end of Induction Phase UC: Change in MES from Day 1 to end of Induction Phase, CD: Change in Global Histopathology Activity Score (GHAS) and RHI from Day 1 to end of Induction Phase UC: Change in Geboes score, RHI, and Nancy Histology Index (NHI) from Day 1 to end of Induction Phase, Descriptive summaries of PK of investigational drug
Interventions
Sponsors
Mirador Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values, Prospective Observer-Blinded Endpoint ISAs: CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase, Randomized Placebo-Controlled ISAs: Proportion of participants with clinical remission at end of Induction Phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with clinical remission at end of Induction Phase, CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase, Proportion of participants with Patient-Reported Outcome-2 (PRO-2) remission at end of Induction Phase, Proportion of participants with clinical response at end of Induction Phase, CD: Proportion of participants with endoscopic and clinical response at end of Induction Phase, UC: Proportion of participants with histologic response at end of Induction Phase, UC: Proportion of participants with histologic remission at end of Induction Phase, UC: Proportion of participants with histologic-endoscopic mucosal improvement at end of Induction Phase, CD: Change in SES-CD from Day 1 to end of Induction Phase UC: Change in MES from Day 1 to end of Induction Phase, CD: Change in Global Histopathology Activity Score (GHAS) and RHI from Day 1 to end of Ind | — |
Countries
Belgium, Bulgaria, Croatia, Czechia, Germany, Italy, Poland, Slovakia
Outcome results
None listed