Windsor

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are investigating the effects of durvalumab, an immunotherapy drug, on various types of advanced or metastatic solid cancers. The study aims to understand how durvalumab works after patients have discontinued prior checkpoint therapy due to immune-related side effects and to evaluate if prednisone, a steroid, can lessen these side effects when given alongside durvalumab. Another part of the study allows patients from completed Canadian Cancer Trials Group (CCTG) studies to continue treatment with durvalumab, with or without tremelimumab. Participants receive durvalumab through an intravenous infusion of 1500 mg over 60 minutes every four weeks. Some patients will also take prednisone orally during the first two treatment cycles, either at 0.5 mg/kg or 10 mg daily doses, to manage potential immune-related side effects. For patients continuing from previous trials, treatment involves durvalumab with or without tremelimumab according to their prior therapy. The study includes two substudies with treatment periods and safety monitoring lasting up to two years. Throughout the study, participants undergo regular assessments including monitoring for side effects, blood tests to check organ function and blood counts, and imaging to track the presence and size of tumors. Researchers carefully record the number and severity of any adverse events. Patients must be available for treatment and follow-up at the study centers, and all must have provided informed consent. The study also involves collecting tumor tissue when available and uses clinical evaluations to monitor patient health and treatment response over the two-year period.

Researchers are evaluating two types of radiation treatments for women with small, node-negative breast cancer (3 cm or smaller) after breast-conserving surgery. The study aims to find out if partial breast irradiation (PBI) given once a day over one week is not worse than whole breast irradiation (WBI) in preventing cancer from coming back locally and if it leads to better cosmetic outcomes as assessed by patients three years after treatment. This is a phase 3 randomized trial focusing on the comparison of these two radiation approaches. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total radiation dose of 26 Gy divided into 5 daily sessions over 5 to 7 days (up to 8 days allowed due to holidays). The radiation is carefully targeted to the appropriate breast area, and the study is single-blinded so that patients do not know which treatment they receive to avoid bias in cosmetic assessments. Treatment planning includes using CT imaging and surgical markers for accurate delivery. During the study, participants will be monitored annually for five years to check for local cancer recurrence. Cosmetic outcomes will be assessed by patients themselves at three and five years post-treatment. Other evaluations include tumor characteristics and receptor status, and treatment safety will be observed. The total participation involves follow-up over several years to understand long-term effects of the treatments.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effectiveness of JNJ-95597528 compared to a placebo in adults with moderate to severe atopic dermatitis, a chronic skin condition. This Phase 2b study aims to assess how well JNJ-95597528 works in improving symptoms in participants who have had the condition for at least one year and meet specific disease severity criteria. JNJ-95597528 and placebo will both be given by subcutaneous injection. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will receive their assigned treatment and be monitored throughout the study to evaluate the drug's impact on their skin condition. Participants will be involved in scheduled visits where their eczema severity will be assessed using the Eczema Area and Severity Index (EASI) among other measures. The primary outcome is the proportion of participants achieving a 75% improvement in EASI at Week 12. Safety and adherence to the treatment plan will also be monitored during the study period.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating new treatment options for people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or has come back after prior treatment. This type of cancer starts in the lining of the uterus and is considered advanced when it has spread locally or to other body parts and cannot be removed by surgery. The study aims to compare the effectiveness of sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate, combined with pembrolizumab versus pembrolizumab alone, to see which approach helps people live longer without the cancer worsening. Participants first receive an induction phase of six cycles, each lasting three weeks, of pembrolizumab combined with carboplatin and either paclitaxel or docetaxel through intravenous infusions. Those whose cancer does not progress after this phase enter the maintenance treatment phase, where they are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer does progress, participants may enter a subsequent treatment phase and be randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During the study, researchers monitor participants for progression-free survival and overall survival for up to approximately 44 and 54 months, respectively. Participants undergo regular imaging, assessments, and laboratory tests to evaluate cancer status and treatment effects. The study also tracks safety and tolerability throughout all phases, providing a comprehensive follow-up to understand treatment impact over time.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.