7 results
The primary efficacy objectives for this study are as follows:* To evaluate the efficacy of etrolizumab (105 mg SC every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the MCS at W14* To evaluate the efficacy of…
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…
The objectives of this open-label extension*safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety…
Induction Phase (IP)* To independently evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing clinical remission and endoscopic improvement at the end of the Induction Phase (Week 14)Maintenance Phase (MP)* To…
Primary objectiveTo confirm the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, in subjects with T1D. This includes comparing the difference in change from baseline in HbA1c between once weekly insulin…
The objectives of this open-label extension safety monitoring (OLE-SM) study are as follows:Part 1 (Open-Label Extension; OLE)• To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE)Part 2 (Safety Monitoring…
Primary objectiveTo demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus regimen. This includes comparing…