6 results
Primary:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0…
Primary objective:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active CD who achieved clinical response at Week 6 following administration of vedolizumab IV…
To determine the ratio of parent drug to metabolites in the circulation.Profiling of [14C]-etripamil metabolites in blood, urine and feces.To determine the mass balance of drug-related materials following intranasal administration.To determine the…
The primary objective of this study is to demonstrate the superiority of etripamil NS over placebo in reducing ventricular rate in patients with AF.
Primary:* To obtain data on long term safety and tolerability on vedolizumab SC in subjects with Ulcerative Colitis (UC) or Crohn's Disease (CD).Secondary:* To obtain data on adverse events of special interest (AESIs; serious infections…
The primary objective of this study is to evaluate the performance of the Navigate Anti-AAV9 Antibody Assay using serum specimens in subjects with SMA in Novartis clinical studies COAV101B12301 *STEER* and COAV101B12302 *STRENGTH*.