Sant Andreu De La Barca

This research evaluates the effects of empasiprubart compared to intravenous immunoglobulin (IVIg) in adults diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition affecting the nerves. The study is a Phase 3 trial aiming to assess the safety and effectiveness of these treatments. Participants must meet specific CIDP diagnostic guidelines and have shown response to IVIg in the past five years. The study is divided into two parts. In Part A, lasting 24 weeks (6 months), participants receive either empasiprubart with a placebo mimicking IVIg, or IVIg with a placebo mimicking empasiprubart. Following this, Part B lasts 96 weeks (24 months), during which all participants receive empasiprubart. Both treatments are given by intravenous infusion. Placebos are used to maintain blinding in the study. Participants will be monitored for changes in their disease symptoms, particularly focusing on improvements measured by a reduction of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (aINCAT) score by week 24. Throughout the study, safety and disease activity will be regularly assessed. The total study duration for participants is up to 120 weeks, including both treatment parts.

Researchers are evaluating the effectiveness of combining autogene cevumeran with nivolumab compared to nivolumab alone as adjuvant treatment for participants with high-risk muscle-invasive urothelial carcinoma (MIUC). The study is a Phase II, randomized, double-blind, multicenter trial aiming to assess disease-free survival and safety in this patient group. This study includes participants who have undergone surgical removal of MIUC and may have received prior treatments such as neoadjuvant chemotherapy or checkpoint inhibitors. The study begins with a safety run-in phase where participants receive both autogene cevumeran and nivolumab to monitor safety. After this phase, additional participants will be randomized to receive either autogene cevumeran plus nivolumab or saline plus nivolumab. All treatments are administered via intravenous infusion according to the specified schedules. The study compares the two treatment approaches to evaluate their impact on preventing cancer recurrence. Participants will be closely monitored throughout the study, with assessments including imaging scans to confirm absence of disease, biomarker analyses from tumor tissue, and regular safety evaluations. The primary outcome measure is investigator-assessed disease-free survival, tracked from randomization until recurrence or death, over approximately six years. Participants' recovery status and overall health will be evaluated throughout the study to ensure safety and treatment adherence.