6 results
Primary objectivesThe primary objective of the study is demonstrate that at least one of the sotrastaurin treatment arms is non-inferior to the active control regimen myfortic + tacrolimus with respect to composite efficacy failure (treated BPAR of…
To assess in term pregnant women with an unfavourable cervix (Bishop score < 6, Appendix1) the effectiveness of induction of labour with a transcervical Foley catheter as compared to induction with misoprostol.
Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with metastatic uveal melanoma (dose expansion).
To assess in term pregnant women with an unfavourable cervix (Bishop score < 6, Appendix1) the effectiveness of induction of labour with a transcervical Foley catheter as compared to induction with prostaglandins.
Is priming of the cervix, as part of induction of labour:* At home cost-effective and safe compared to the hospital?* with oral misoprostol cost-effective and safe compared to a Foley catheter?
To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.