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 objective is to minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on day 3 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-…
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…
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…
To minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on day 3, 7 and 10 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-based approach.…
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…