Stalowa Wola

Researchers are evaluating the proposed biosimilar MB04 compared to Enbrel, a known treatment, in patients with moderate to severe rheumatoid arthritis RA who continue to have active disease despite methotrexate therapy. The study aims to assess the effectiveness, safety, how the body processes the drugs, and immune responses to MB04 versus Enbrel. This phase 3 trial will include approximately 458 patients aged 18 to 75 years. Participants will receive a stable dose of methotrexate and folic acid before starting the study. They will be randomly assigned to receive a 50 mg weekly subcutaneous injection of either MB04 or EU-sourced Enbrel during the 36-week main treatment period. After 24 weeks, some patients initially on Enbrel will be re-randomized to either continue Enbrel or switch to MB04, while those on MB04 will continue the same treatment. Following treatment, patients will be monitored for safety for an additional 4 weeks. Throughout the study, patients will undergo regular assessments including measures of joint swelling and tenderness, and blood tests to evaluate inflammation and immune response. The primary outcome is the American College of Rheumatology 20% Response Criteria ACR20 at Week 24, with additional assessments at Week 36. Safety will be monitored continuously, and participant involvement will last approximately 40 weeks including follow-up.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.