12 results
Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical response at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
The primary objective of the study is to determine the effect of atazanavir-induced hyperbilirubinemia on systemic activation of the innate immune response induced by human endotoxemia.Secondary objectives are:- To determine if the vascular…
Primary Objective for the Induction Phase* To determine the effect of MLN0002 induction treatment on clinical remission at 6 weeksPrimary Objective for the Maintenance Phase* To determine the effect of MLN0002 maintenance treatment on clinical…
Primary Objective• To determine the effect of vedolizumab induction treatment on clinical remission at Week 6 in the subgroup of patients defined as having failed tumor necrosis factor alpha (TNFa) antagonist therapy (TNFa subpopulation)Secondary…
Our primary objective is to investigate whether noradrenaline exerts immunomodulatory effects in humans in vivo during experimental human endotoxemia. This will be determined by comparing plasma levels of various pro- and anti-inflammatory cytokines…
Study Objectives:Primary Objective* To determine the safety profile of long-term MLN0002 treatmentResource Utilization and Patient-Reported Outcome Objectives* To determine the effect of long-term MLN0002 treatment on time to major inflammatory…
This study will evaluate the safety, efficacy, and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in patients with moderate to severe ulcerative colitis (UC).
- To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l…
The primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active UC in an 'early' and a 'late' disease…
Primary Objective:To evaluate vedolizumab PK in pediatric subjects with UC or CD.Secondary Objectives:* To assess the efficacy of vedolizumab IV in pediatric subjects with UC or CD.* To characterize the dose-response relationship of vedolizumab IV…
Primary Objectives:To evaluate the proportion of subjects with fistula healing at Week 30 with 2 different dose regimens of vedolizumab IV 300 mg in subjects with perianal fistulizing CD.Secondary Objective:To evaluate fistula healing over a 30-week…
Primary Objective:To compare the efficacy of vedolizumab IV and placebo in terms of the percentage of subjects with chronic or recurrent pouchitis achieving clinically relevant remission.Secondary Objectives:To assess the efficacy of vedolizumab IV…