Santa Maria Da Feira

Researchers are evaluating the clinical efficacy, safety, and tolerability of XEN1101 as an additional treatment for people with focal-onset seizures in a Phase 3 randomized, double-blind, placebo-controlled study. This trial aims to compare two doses of XEN1101 with a placebo to see how well the medication can reduce seizure frequency in patients who continue their current antiseizure medications. The study involves adults diagnosed with focal epilepsy who have tried at least two antiseizure medicines without achieving seizure freedom. About 360 participants will be randomly assigned to receive either 25 mg or 15 mg of XEN1101 or a placebo once daily with an evening meal. The study includes up to 9.5 weeks of baseline monitoring to track seizure frequency followed by 12 weeks of blinded treatment. Participants maintaining the study drug can then join an open-label extension to continue treatment or enter an 8-week follow-up after treatment ends. Throughout the study, participants will keep accurate seizure diaries and continue their stable antiseizure medications. Researchers will measure the median percentage change in seizure frequency from baseline through the 12-week treatment period, along with secondary outcomes like the proportion of participants with at least a 50 reduction in seizures and patient-reported improvement. Safety will be monitored from screening until 56 days after the last dose. Overall, participants are involved for the baseline, treatment, and follow-up phases lasting several months.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the efficacy and safety of Afimkibart also called RO7790121 as both induction and maintenance therapy for people with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart treatment with placebo in participants who have shown inadequate response or intolerance to other Crohns disease therapies. Participants will be randomly assigned to receive either Afimkibart or placebo. Those on Afimkibart will get an intravenous IV infusion followed by subcutaneous SC injections, while the placebo group receives matching IV and SC placebo treatments. The study involves treatment through induction and maintenance phases, continuing up to 52 weeks. During the study, participants will undergo evaluations of their Crohns disease activity using clinical remission and endoscopic response measures at weeks 12 and 52. Researchers will also monitor symptoms such as stool frequency, abdominal pain, fatigue, and bowel urgency, along with quality of life assessments. Safety will be tracked for up to 70 weeks after baseline, including monitoring adverse events and presence of fistulas. The total duration of participation may extend through this period for comprehensive assessment.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart RO7790121 compared to placebo in people with moderately to severely active ulcerative colitis UC. This Phase III, multicenter, double-blind, placebo-controlled study aims to understand how well Afimkibart works and its safety profile in this population. Participants will be randomly assigned to receive either Afimkibart or a placebo. Those in the Afimkibart group will receive the drug first through an intravenous IV infusion followed by a subcutaneous SC injection. The placebo group will receive matching placebo treatments by IV and SC as well. The study treatment period includes these induction therapies, with monitoring continuing up to 30 weeks for safety. During the study, participants will be assessed for clinical remission at 12 weeks, which is the primary outcome. Other evaluations include changes in partial Modified Mayo Score, endoscopic improvement and remission, histologic improvements, bowel urgency, abdominal pain, fatigue, and health-related quality of life. Safety will be monitored by recording adverse events throughout the study. Participants will have visits for these assessments and monitoring over the course of the study duration.

Researchers are evaluating the effectiveness and safety of induction therapy using Afimkibart RO7790121 in people with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled trial aims to understand how well this treatment works compared to placebo during the induction phase. The study focuses on participants who have not responded adequately to other conventional or advanced therapies for Crohns disease. Participants will be randomly assigned to receive either Afimkibart through an intravenous IV infusion followed by subcutaneous SC injections or a placebo IV infusion followed by Afimkibart SC injections. This treatment schedule is designed to assess the induction effectiveness of Afimkibart in reducing disease activity over a 12-week period. The study includes two treatment groups to compare outcomes between the active drug and placebo. During the study, participants will be monitored for clinical remission and endoscopic response at week 12, along with other measures such as symptomatic remission, bowel urgency, abdominal pain, stool consistency, fatigue, and quality of life questionnaires. Safety assessments will continue for up to 30 weeks after baseline to record any adverse events. Participants will attend scheduled visits for evaluations and laboratory tests to track progress and response to treatment throughout the trial.

Researchers are evaluating the clinical efficacy, safety, and tolerability of XEN1101 as an additional treatment for people with primary generalized tonic-clonic seizures PGTCS, a type of generalized epilepsy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants aged 12 years and older who continue to have seizures despite treatment with 1 to 3 anti-seizure medications. The study aims to assess how XEN1101 impacts seizure frequency and overall patient safety. Participants will be randomly assigned to receive either XEN1101 capsules or placebo. Those aged 18 years and older will receive 25 mg of XEN1101 or placebo, while participants aged 12 to under 18 years may receive 15 mg, 25 mg, or placebo. After a baseline period of up to 9.5 weeks to document seizure frequency, participants will enter a 12-week double-blind treatment phase where they take the assigned medication once daily with an evening meal. After this, participants can join an open-label extension to continue XEN1101 treatment or enter an 8-week follow-up phase. Throughout the study, participants will keep seizure diaries and undergo assessments to monitor seizure frequency and safety. The main outcome measure is the median percent change in monthly PGTCS frequency from baseline through the 12-week treatment period. Safety and tolerability will be closely observed, and participants will be followed for a total of at least 20 weeks including baseline, treatment, and follow-up periods to evaluate the long-term effects of XEN1101.

Researchers are evaluating the safety and tolerability of RO7121932 given by intravenous IV and subcutaneous SC routes in adults with multiple sclerosis MS. This Phase 1 study tests different single ascending doses and multiple ascending doses to understand how the body processes the drug and its effects on participants with relapsing or progressive MS who are not currently on approved MS treatments. Participants will receive RO7121932 either as a single IV dose starting at 7 mg and increasing up to 2000 mg, a single SC dose starting at 70 mg escalating to 200 mg, or multiple weekly SC doses ranging from 70 mg to 700 mg over 22 days. Dose adjustments may occur based on emerging safety and tolerability data. The study includes three parts Part 1 with single ascending IV doses, Part 2 with single ascending SC doses, and Part 3 with multiple ascending SC doses. During the study, participants will be monitored closely for adverse events and changes in suicide risk over several months. Assessments include injection site reactions, blood and cerebrospinal fluid sampling to measure drug concentration and immune cell changes, and antibody development against RO7121932. The study tracks pharmacokinetics and pharmacodynamics over up to 197 days depending on the treatment part, with safety and immune effects as key outcomes.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are evaluating maridebart cafraglutide in adults aged 45 to 99 years who have atherosclerotic cardiovascular disease and are overweight or obese. The study aims to determine if maridebart cafraglutide, when added to standard care, is better than a placebo in reducing serious heart-related problems and deaths. This is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Amgen. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is given alongside their usual care. The trial will last for approximately 35 months, during which time researchers will monitor cardiovascular events such as heart attacks, strokes, and deaths, as well as other health measures. During the study, participants will have regular visits for monitoring safety and health status. Researchers will assess heart-related events, blood pressure, body measurements, blood markers such as cholesterol and blood sugar levels, and kidney function. The main outcomes include time to first major cardiovascular event and changes in various health indicators over about three years. Safety monitoring will continue throughout the trial period.