Sassari

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating the use of benralizumab in adults with severe eosinophilic asthma to understand its effectiveness in achieving partial and complete clinical remission. This multicenter, observational, prospective study called the ATHENA study aims to add real-world evidence on benralizumab's role in clinical practice. The study also seeks to explore the immunological effects of benralizumab to better understand asthma biology and to collect long-term safety data. Participants will receive benralizumab, administered as a 30mg subcutaneous injection following the approved prescribing information. The study focuses on patients who have either recently started benralizumab treatment within 7 days before enrollment or plan to start within 7 days after enrollment. Treatment and monitoring will follow routine clinical practice without additional interventions. During the study, researchers will track the number and percentage of patients who achieve clinical remission according to the SANI definition over 24 months. Participants will be closely monitored for treatment effectiveness, immunological changes, and safety outcomes throughout this period. The study involves collecting relevant clinical data and ensuring participants adhere to treatment and follow-up visits as per standard care.

Researchers are studying the clinical and health-related outcomes of treatments containing amivantamab for people with common EGFR-mutated advanced non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. This type of cancer can spread to other parts of the body and occurs due to changes in genes such as the epidermal growth factor receptor (EGFR). The study focuses on real-world use of these treatments outside of controlled clinical trials. Participants will receive amivantamab-containing regimens as part of their standard care, decided by their doctors according to approved guidelines and local recommendations for supportive medications. The study observes patients starting these treatments for the first time and follows their clinical course as they receive care in usual medical settings. During the study, researchers will collect data for up to approximately 60 months to understand how long patients continue treatment and other health outcomes. Data collection includes monitoring treatment use, clinical responses, and safety in a real-world context. Participants or their representatives must provide consent for data verification, and the study tracks outcomes during routine clinical visits without altering standard treatment practices.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating patient-reported satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in adults with lung cancer or hepatocellular carcinoma treated in routine clinical practice. This non-interventional, multicenter, multicountry study collects primary data on health-related quality of life and treatment satisfaction for participants receiving Atezolizumab for approved indications. The study focuses on patients with specific lung cancer subtypes and advanced liver cancer who meet defined criteria regarding prior treatments and tumor characteristics. Atezolizumab is given subcutaneously at the discretion of the treating physician independently of study participation. Patients eligible for the study include those with early-stage or metastatic non-small cell lung cancer (NSCLC) with specific PD-L1 expression and genetic profiles, extensive-stage small cell lung cancer (ES-SCLC), and advanced or unresectable hepatocellular carcinoma (HCC) not previously treated with systemic therapy. Treatment administration follows routine clinical practice, with no experimental interventions assigned by the study. Participants complete questionnaires assessing their satisfaction with Atezolizumab treatment and health-related quality of life during cycles 2 and 3 of therapy, each lasting three weeks. The primary outcome measure is the Therapy Administration Satisfaction Questionnaire Subcutaneous (TASQ-SC) score at these cycles. Safety and effectiveness data are monitored as part of routine care. The study collects data on patient experiences to better understand the real-world use of Atezolizumab over the treatment period.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are studying the treatment LTP001 in two groups: healthy adults (Part A) and adults with pulmonary arterial hypertension (PAH) (Part B). The study aims to evaluate the safety, tolerability, and how the body processes LTP001 in healthy volunteers, and to assess the safety and effectiveness of LTP001 in participants with PAH. This trial includes a safety extension period for participants with PAH to monitor longer-term effects. In Part A, healthy adult participants will receive single and multiple ascending doses of LTP001 or placebo to assess safety and pharmacokinetics. Part B involves participants with confirmed PAH who will receive LTP001 or placebo alongside their standard PAH treatments. The study monitors participants from baseline through various treatment periods, including a treatment period of up to 106 weeks in Part B for long-term safety assessment. Participants will undergo evaluations including monitoring for adverse events and serious adverse events from baseline through Day 35 in Part A and through Week 106 in Part B. The study also measures changes in pulmonary vascular resistance (PVR) during Part B at Week 24. Assessments include physical exams, ECGs, and walking tests to evaluate heart and lung function. Researchers will track safety, efficacy, and tolerability throughout the study duration.

Researchers are evaluating if combining atezolizumab with standard chemotherapy can improve treatment for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer (ES-SCLC) after progression following first-line treatment. This phase II multicenter study aims to determine whether this combination increases overall survival and to identify any medical problems participants may experience. Sensitive relapse is defined as cancer returning or progressing at least 60 days after completing initial chemo-immunotherapy including PD-L1 inhibitors like atezolizumab or durvalumab. Participants will receive rechallenge chemotherapy consisting of carboplatin plus etoposide at doses chosen by the investigator along with atezolizumab 1200 mg intravenously on day 1 every 3 weeks. This induction phase lasts up to 4 cycles. After that, participants continue with maintenance atezolizumab every 3 weeks for up to 18 cycles or 1 year, unless disease progression, unacceptable toxicity, or other stopping criteria occur. The study treatment period can last up to 15 months. Radiological assessments with CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to monitor response. Participants attend clinic visits every 3 weeks for treatment and assessments. Researchers continuously monitor for side effects and safety throughout the study. The total study duration is up to 45 months, including about 24 months for enrollment, treatment up to 15 months, and 6 months of survival follow-up. The main outcome measured is overall survival through study completion, averaging 1 year.

Researchers are studying Alzheimer's disease (AD), particularly focusing on how it progresses and how to detect it early. This study aims to better understand the brain's neurophysiological changes in people with mild AD, those with mild cognitive impairment (MCI), and healthy individuals. It also investigates how inflammation affects AD progression using a mouse model, with the goal of developing new biomarkers and anti-inflammatory treatments using special nanoparticles. The study observes brain connectivity networks, which deteriorate early in AD, to find markers that distinguish between mild AD, MCI, and healthy brains. In the mouse model, researchers test innovative biomimetic nanoparticles designed to shift brain immune cells to an anti-inflammatory state, potentially affecting disease progression. These approaches combine human studies with preclinical experiments to explore disease mechanisms and therapeutic options. Participants will be monitored for about one year, during which researchers will identify disease-related brain patterns and early intervention markers. They will use EEG-based brain network analyses to predict progression from MCI to AD, and assess how the activated nanoparticles interact with brain inflammation and immune cells. This comprehensive monitoring includes evaluating brain connectivity, inflammation markers, and treatment effects to better understand and track dementia progression.