Stockton

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating the safety and tolerability of acalabrutinib, taken as a monotherapy 100 mg twice daily by mouth, compared to the investigator's choice of treatment in adults with chronic lymphocytic leukemia (CLL) who also have moderate to severe heart failure. This Phase IV, open-label, randomized study focuses on patients with cardiac impairment defined by a left ventricular ejection fraction (LVEF) below 50%. The study aims to assess cardiovascular and other adverse events related to these treatments over an extended period. Participants will be randomly assigned to receive either acalabrutinib or a treatment chosen by their investigator, which may include drugs like chlorambucil, venetoclax, ibrutinib, zanabrutinib, rituximab, or obinutuzumab. Treatment cycles last 28 days, with hematology visits at the start of each cycle for the first eight cycles and every four cycles afterward. Cardiology assessments including echocardiogram, ECG, Holter monitoring, cardiac biomarkers, and possibly cardiac MRI will be done regularly during treatment and follow-up. Decisions about treatment changes due to cardiac side effects involve collaboration between the principal investigator and a cardiologist. Patients will be closely monitored through scheduled visits during treatment and after discontinuation, up to four years from the last patient randomized. Assessments include safety checks, cardiac evaluations, disease response per established criteria, and survival status updates every 16 weeks once disease progresses. The study's primary focus is on cardiovascular safety endpoints, including serious and fatal cardiac events, adverse event frequency, and treatment discontinuation rates related to side effects.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.