Osterwieck

Researchers are evaluating the safety, tolerability, and effectiveness of combining Imzokitug with Pumitamig and Platinum-Doublet Chemotherapy PDCT compared to Pumitamig and PDCT alone. The study focuses on adults with locally advanced or metastatic non-small cell lung cancer NSCLC who have not received previous systemic therapy for advanced or metastatic disease. This is a Phase 2 interventional trial assessing first-line treatments for this condition. Participants will receive either the combination of Imzokitug, Pumitamig, and PDCT or Pumitamig with PDCT alone. Treatment involves specified doses given on certain days, with tumor tissue samples required for analysis. The study is randomized and parallel in design, with multiple experimental arms. The primary treatment period extends up to approximately four years, during which the response to therapy will be closely monitored. Throughout the trial, participants will undergo evaluations including tumor assessments using RECIST v1.1 criteria to measure objective response rates. Safety will be monitored by documenting adverse events, serious adverse events, and treatment-related effects up to 90 days after the last treatment. Researchers will also track progression-free survival, overall survival, duration of response, and time to recurrence during the study and follow-up periods. The trial is sponsored by Bristol-Myers Squibb and aims to collect comprehensive data over several years.

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.

Researchers are investigating Prodromal Parkinsons Disease by studying the progression of 18F AV-133 PET imaging in participants who show early signs of Parkinsons but have not yet developed typical symptoms. This observational study is part of the Parkinsons Progression Marker Initiative PPMI, aiming to identify biomarkers that signal disease progression and help improve future treatments. The study is international and multi-center, with participants followed for up to 24 months to better understand the disease course during this early stage. Participants will undergo three 18F AV-133 PET imaging scans targeting the vesicular monoamine transporter at the beginning of the study, at 12 months, and at 24 months. Approximately 100 prodromal Parkinsons participants enrolled in the PPMI Clinical 002 study will receive these imaging procedures at up to 10 sites. The study focuses on monitoring changes over time through this specialized imaging technique. During the study, participants will have comprehensive assessments including motor, neuropsychiatric, cognitive, imaging, and biomarker evaluations based on the PPMI Clinical protocol. Researchers will measure the mean rate of change and variability in 18F AV-133 imaging over 24 months, along with clinical motor and cognitive progression and correlations with other clinical and imaging outcomes. Safety will also be monitored by tracking treatment-emergent adverse events throughout the 24-month follow-up period.

Researchers are conducting the Parkinsons Progression Marker Initiative PPMI, a large, multi-center, observational study to track the progression of Parkinsons disease PD over time. This study includes participants with diagnosed PD, those at risk prodromal PD, and healthy controls. It aims to identify markers related to PD progression by collecting clinical, digital, imaging, biological, and genetic data, which could help in developing therapies to slow PD disability progression. PPMI Clinical plans to enroll up to 4,500 participants who will be followed for 5 to 8 years. Participants may also be invited to join additional related programs such as PPMI Remote, PPMI Digital App, or PPMI Online, depending on their recruitment method and cohort classification. The study collects a wide range of data including clinical assessments, digital outcomes, imaging scans, biological samples, and genetic testing. Participants may undergo repeated evaluations, including imaging tests like SPECT, and provide information through questionnaires and digital tools. Throughout the study, participants will attend visits at regular intervals to undergo assessments that help researchers measure disease progression and compare changes over time. Data collected includes clinical signs, imaging results, biological markers, and genetic information. The study also monitors the probability of disease development in at-risk individuals. The overall duration of participation can extend up to 13 years, ensuring comprehensive long-term data collection and safety monitoring.