Moderately to Severely Active Ulcerative Colitis
Conditions
Brief summary
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs, Changes in clinical laboratory parameters, electrocardiogram parameters, and vital signs, Change from baseline in 3-component modified Mayo Clinic Score (MMCS) (defined as sum of stool frequency subscore [SFS], rectal bleeding subscore [RBS], and Mayo endoscopic subscores [MES]a) at Week X
Detailed description
Proportion of participants who achieve clinical remission defined as 3‑component MMCS ≤2 (SFS ≤1, RBS = 0, and MES ≤1) at Week X, Proportion of participants who have a clinical response per 3 component MMCS (defined as a decrease from baseline of ≥2 points and ≥30%, and either a decrease in RBS of ≥1 point or an absolute RBS of 0 or 1) at Week X, Proportion of participants who achieve clinical remission per MMCS at Week X, Proportion of participants who have a clinical response per MMCS at Week X
Interventions
Sponsors
Odyssey Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest and treatment discontinuations due to TEAEs, Changes in clinical laboratory parameters, electrocardiogram parameters, and vital signs, Change from baseline in 3-component modified Mayo Clinic Score (MMCS) (defined as sum of stool frequency subscore [SFS], rectal bleeding subscore [RBS], and Mayo endoscopic subscores [MES]a) at Week X | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieve clinical remission defined as 3‑component MMCS ≤2 (SFS ≤1, RBS = 0, and MES ≤1) at Week X, Proportion of participants who have a clinical response per 3 component MMCS (defined as a decrease from baseline of ≥2 points and ≥30%, and either a decrease in RBS of ≥1 point or an absolute RBS of 0 or 1) at Week X, Proportion of participants who achieve clinical remission per MMCS at Week X, Proportion of participants who have a clinical response per MMCS at Week X | — |
Countries
Austria, Belgium, Croatia, Czechia, Hungary, Lithuania, Poland
Outcome results
None listed