Leiria

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are investigating the effect of a physical activity coaching program delivered through an eHealth platform on patients with Chronic Obstructive Pulmonary Disease (COPD) undergoing pulmonary rehabilitation. This study aims to see if this coaching can improve physical activity levels and health outcomes. The trial involves patients who are clinically stable with COPD and enrolled in pulmonary rehabilitation. All participants will take part in a 10-week pulmonary rehabilitation program consisting of 20 sessions held twice a week. The program includes aerobic and strength exercises, education on medication, smoking cessation, energy conservation, stress management, breathing control, inhaled therapy, nutrition, and counseling. At week 5, the experimental group will begin a personalized physical activity coaching intervention delivered via a mobile app and web platform, continuing for 6 months after rehabilitation ends. Coaching includes weekly goal setting based on patient performance and motivation, daily notifications about goal achievements, and personalized messages from researchers. Participants will be assessed at the start, midpoint, and end of pulmonary rehabilitation, as well as 3 and 6 months after completing the program. Assessments include monitoring daily step counts using accelerometers. Researchers will track physical activity changes, health-related outcomes, and adherence to the intervention. The study monitors safety and effectiveness throughout the intervention and follow-up periods.

This trial focuses on adults aged 18 to 70 diagnosed with Major Depressive Disorder (MDD) who have elevated inflammation biomarkers, specifically C-reactive protein (CRP) and Interleukin 6 (IL-6). The study aims to evaluate whether promoting adherence to the Mediterranean Diet (MedDiet) can reduce symptoms of depression in these patients, who are already receiving antidepressant medication. The research also seeks to understand the relationship between diet adherence, changes in inflammation, psychiatric treatment effectiveness, quality of life, and the economic cost-effectiveness of dietary counseling as an additional treatment. Participants will be randomly assigned to one of two groups for 12 weeks: the intervention group will receive six personalized nutrition consultations promoting the MedDiet alongside their usual depression treatment, while the control group will continue with their usual treatment alone. The dietary guidance encourages increased consumption of olive oil, vegetables, fruits, legumes, fish, nuts, poultry, and home-cooked meals, and reducing intake of cream, butter, processed meats, sugary drinks, pastries, fried foods, and limiting alcohol intake. Follow-up assessments will occur at 6 and 12 months after the initial evaluation. During the study, participants will undergo assessments at baseline, 12 weeks, 6 months, and 12 months to measure changes in depression symptoms using the Beck Depression Inventory II (BDI-II). Inflammatory biomarkers will also be monitored, along with health-related quality of life and treatment effectiveness. The study will include blood tests, questionnaires, and nutritional consultations, with data analyzed to compare depression symptom changes between the intervention and control groups. This trial plans to enroll a minimum of 190 participants, accounting for potential dropout rates.

Researchers are investigating whether adjusting exercise intensity to increase pleasure and arousal can improve physical activity behavior in patients who experienced acute coronary syndrome (ACS) during a cardiac rehabilitation program. The study focuses on comparing physical activity levels and emotional responses between an experimental group with pleasure-oriented exercise intensity and a control group following a conventional exercise program. ACS patients face risks like heart failure and reduced quality of life, making prevention and physical activity crucial for recovery and long-term health. Participants will attend sixteen personalized exercise sessions over eight weeks (two sessions per week) during phase 2 of a cardiac rehabilitation program. Both groups receive pre-exercise evaluations and follow the European Association of Preventive Cardiology guidelines for exercise, including a complementary physical activity program for daily life. The experimental group’s exercise intensity is carefully adjusted to promote pleasurable experiences while respecting safety limits, while the control group follows a standard intensity program with health benefit education. During the study, participants’ physical activity will be measured using questionnaires and accelerometers before, immediately after, and three months following the intervention. Affective responses will be monitored during exercise sessions at regular intervals. Researchers will assess adherence, motivation, and emotional reactions to exercise, aiming to understand how pleasure-focused intensity impacts long-term physical activity behavior and recovery. The program includes ongoing evaluations, feedback, and follow-up to support sustained lifestyle changes.

Researchers are evaluating the effectiveness of Ofatumumab treatment in patients with relapsing multiple sclerosis (RMS) in Portugal. The study compares patients who started Ofatumumab within three years of their RMS diagnosis to those who began treatment more than three years after diagnosis. This observational study reflects real-world medical care and aims to understand how timing of treatment initiation might impact disease activity. The study includes two groups of patients based on when they started Ofatumumab: early initiators and later initiators. Ofatumumab is prescribed by physicians according to local guidelines, and no medication is provided by the study sponsor. Data will be collected during three visits over a maximum of 24 months. If a patient's disability worsens at the 12- or 24-month visits, an additional follow-up visit will be conducted 6plus or minus 1 month later to confirm this change. Participants will undergo assessments including patient-reported outcome questionnaires and disability status evaluations. The main outcome measured is the proportion of patients showing no evidence of disease activity (NEDA-3) from month 12 to month 24. The study requires patients to have been treated with Ofatumumab for at least two years. The total participation period may extend up to 24 months, with additional visits if disability progression is suspected.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

Polypoidal choroidal vasculopathy (PCV) is a type of choroidal blood vessel disease that can cause bleeding and fluid buildup in the eye, leading to vision loss. Its exact cause is still unclear, and while it may be a subtype of age-related macular degeneration, it is often underdiagnosed, especially in Caucasian populations. This trial aims to evaluate the effectiveness, safety, and lasting effects of faricimab, a new antibody treatment, in Caucasian patients with symptomatic macular PCV. Participants will receive intravitreal injections of faricimab 6 mg following a personalized treat and extend schedule. The study includes a screening period up to 28 days, a 12-week treatment initiation phase, and a treat and extend phase lasting approximately 100 weeks. No control group will be used, and treatment intervals may extend up to 24 weeks depending on response. During the study, participants will undergo thorough eye exams, safety checks, and visual acuity tests to monitor changes in best corrected visual acuity from the start through Weeks 40, 44, or 48. Researchers will collect retinal images and assess safety throughout the treatment period. The study focuses on evaluating vision improvements and the durability of faricimab treatment over nearly two years.