Campulung

Researchers are evaluating the efficacy and safety of empasiprubart in adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP. This Phase 3, randomized, double-blinded, placebo-controlled study compares empasiprubart to placebo to better understand its impact on CIDP symptoms and disease progression. The study has two parts Part A lasts 24 weeks 6 months, where participants receive either empasiprubart or placebo via intravenous infusion. After Part A, all participants enter Part B for 96 weeks 24 months during which everyone receives empasiprubart. Participants who received empasiprubart in Part A will receive a placebo dose once during Part B to maintain the study blind. Participants will have regular assessments including measurements of disability using the adjusted inflammatory neuropathy cause and treatment aINCAT score, grip strength, and other neurological and quality of life scales. Safety is monitored throughout the study. The total participation period spans up to 120 weeks, with evaluations at multiple time points to track changes from baseline and any adverse events.

Researchers are evaluating the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis SPMS. This is a Phase III, randomized, double-blind, placebo-controlled, multi-center study involving approximately 1275 participants. The study aims to provide important data on remibrutinibs effect on disability progression in SPMS and includes both a Core Part and an Extension Part for further assessment. Participants are randomly assigned to receive either remibrutinib or a matching placebo as oral film-coated tablets during the Core Part. The Core Part includes double-blind treatment, followed by an Extension Part where all participants receive open-label remibrutinib tablets. Treatment is taken orally, and the study is event-driven, continuing until required endpoints are met. During the study, participants undergo regular assessments of disability progression using the Expanded Disability Status Scale EDSS, Timed 25-Foot Walk, 9-Hole Peg Test, and Symbol Digit Modalities Test, among others. Brain imaging and safety monitoring for adverse events are performed throughout up to approximately five years. Researchers track changes in brain lesions and atrophy, and follow participants for safety and treatment effects over time.