6 results
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
Part I (single ascending dose):To evaluate the safety and tolerability of ascending single doses of DRL-17822 in healthy male subjects;To evaluate the pharmacokinetics of ascending single doses of DRL-17822 in healthy male subjects;To determine CETP…
Primary ObjectiveThe primary objective of the study is:• To compare the efficacy of 6.0, 7.5, and 9.0 g of FT218 to placebo in treating EDS in both NT1 and NT2 subjects as measured by mean sleep latency on the Maintenance of Wakefulness Test (MWT)…
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.