5 results
The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-,…
Primary Objective* To assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. Secondary Objectives* To assess the…
Main objective:To assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis (LN)Secondary objective:To assess the safety and tolerability of Orelvo…
Phase 2:• To assess the safety, tolerability, systemic exposure, and efficacy of AMT-101 in subjects with chronic antibiotic-resistant pouchitis• To select an AMT-101 dose for Phase 3Phase 3:Co-primary Objectives:• To determine the effect of AMT-101…
To evaluate the effects of AMT-101 in combination with adalimumab on UC disease activity as measured by symptoms, endoscopy, histology, and biomarkers. To evaluate the safety and tolerability of oral AMT-101 over 8 weeksTo assess the PK parameters…