Zory

Researchers are evaluating the effectiveness and safety of remibrutinib in adults aged 18 to 65 years with secondary progressive multiple sclerosis (SPMS). This Phase III study is randomized, double-blind, and placebo-controlled, designed to better understand how remibrutinib affects disability progression in SPMS patients over time. Participants will be randomly assigned to receive either oral remibrutinib tablets or matching placebo tablets during the Core Part of the study, which is event-driven and double-blinded. After this period, all participants may enter an Extension Part where they receive open-label remibrutinib treatment. This design allows researchers to compare remibrutinib against placebo and then monitor long-term effects when all participants receive the active drug. Throughout the study, participants will undergo regular assessments including MRI scans and clinical evaluations to track changes in disability using the Expanded Disability Status Scale (EDSS). The primary outcome measured is the time to confirmed disability progression over six months, with follow-up lasting up to approximately five years. Safety, tolerability, and other health parameters will also be closely monitored during both study phases.

Researchers are investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.

Researchers are evaluating a modified regimen of ublituximab in adults with relapsing multiple sclerosis (RMS) to assess its effectiveness and safety. The study is a phase 3b trial consisting of three parts: Part A is open-label and single-arm, Part B is randomized, double-blind, and placebo-controlled, and Part C is open-label focusing on participants who had a suboptimal response to prior anti-CD20 therapy. The main goal is to measure changes in T1 Gadolinium-enhancing lesions in the brain to see how well the treatment works. Participants receive ublituximab or placebo through intravenous (IV) infusions during different parts of the study. Part A and Part C involve ublituximab infusions, while Part B compares ublituximab to placebo infusions. Part C includes participants who have been treated with an anti-CD20 agent for at least six months but had suboptimal results and meet specific washout requirements before beginning this study. During the study, participants undergo regular assessments, including brain MRI scans to monitor T1 Gd-enhancing lesions over 48 weeks and pharmacokinetic measurements up to 16 weeks. Researchers also evaluate safety and treatment responses throughout the study. The trial includes adults aged 18 to 65 with stable neurological status and a disability score of 5.5 or less. Female participants of childbearing potential must use contraception during and after the study. Total participation time varies based on the study part and treatment schedule.