Luneburg

Researchers are evaluating the effects of pelacarsen TQJ230, given as a monthly subcutaneous injection, on slowing the progression of calcific aortic valve stenosis in adults aged 50 to under 80 years with elevated Lipoproteina levels. This phase 2, randomized, double-blind, placebo-controlled multicenter trial aims to assess the efficacy, safety, and tolerability of pelacarsen compared to a matching placebo. The study is sponsored by Novartis Pharmaceuticals and focuses on patients with mild to moderate calcific aortic valve stenosis who are optimally treated for cardiovascular risk factors. Participants receive either pelacarsen 80 mg or a placebo via a prefilled syringe injected under the skin once every month. The study includes two groups one receiving the active drug and the other receiving a placebo, both administered in the same way. The trial will last up to 36 months, during which patients will be monitored for changes in aortic valve function and calcium levels. Throughout the study, participants will undergo evaluations including measurement of peak aortic jet velocity and aortic valve calcium scores at 36 months. Additional assessments include changes in Lipoproteina levels at 12 months and monitoring of fibrocalcific thickening of the valve and clinical events over the course of the trial. Safety will be closely monitored to ensure participants well-being during the entire study period.

Researchers are conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light sNfL as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis MS. The study focuses on patients who have received category 1 disease-modifying therapies DMTs and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physicians clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.

Researchers are studying severe eosinophilic asthma patients who are treated with benralizumab in everyday medical settings in Germany. This prospective observational study aims to understand how well asthma is controlled, how patients quality of life is affected, changes in lung function, and medication use over time. The study focuses on patients receiving high-dose inhaled corticosteroids plus long-acting beta agonists and prescribed benralizumab according to approved guidelines. Patients will be followed for up to 52 weeks while they receive their usual benralizumab treatment without any changes directed by the study. Asthma control will be assessed using standard tests like the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQ at various times. Quality of life will be measured with the mini Asthma Quality of Life Questionnaire miniAQLQ at the start and during routine visits. Patients will also keep a weekly record of their asthma medication intake using a paper or electronic diary. During the study, participants will have regular assessments of asthma control, lung function, and medication usage. Researchers will analyze changes in scores from questionnaires, doses of inhaled corticosteroids, and lung function measures such as forced expiratory volume and capacity. Biomarkers including eosinophils, immunoglobulin E, and exhaled nitric oxide will be monitored. The study will evaluate outcomes at baseline and weeks 12, 24, and 52 to better understand real-life effects of benralizumab treatment. Participants must be willing to regularly report their symptoms and medication use throughout the study period.

Researchers are evaluating the effectiveness, safety, and tolerability of oral icotrokinra in treating adults and adolescents with moderately to severely active ulcerative colitis UC, a chronic condition where the large intestine lining becomes inflamed and develops ulcers. This Phase 3 clinical trial aims to compare icotrokinra with a placebo to better understand its impact on UC symptoms and remission rates. Participants will be divided into study groups receiving either icotrokinra or a placebo orally each day starting from Week 0 of the induction phase. After 12 weeks, responses will be assessed and participants who respond to icotrokinra or placebo enter a maintenance phase lasting up to Week 40. Adolescents receive open-label icotrokinra throughout the study, with an option for a long-term extension after completing the maintenance phase. During the trial, participants will undergo regular evaluations including clinical response, endoscopic assessments, and symptom monitoring at key points such as Weeks 12 and 40. Researchers will track remission rates, symptom improvements, quality of life, and safety outcomes. The study involves both double-blind and open-label phases and continues until January 2032, with close monitoring to understand how participants respond over time.

Researchers are evaluating how well icotrokinra works and how safe it is for people with moderately to severely active Crohns disease, a condition that causes long-term inflammation in the intestines. This study is a Phase 2b3 trial that aims to understand both the effectiveness and safety of icotrokinra in treating this condition. Participants will receive icotrokinra or a matching placebo orally every day during the induction period lasting up to 12 weeks. Those who respond to the treatment at Week 12 may continue with different dosing options of icotrokinra or placebo during a maintenance phase up to Week 40. Following this, eligible participants can join a long-term extension study to further monitor treatment effects. During the study, participants will undergo evaluations of their clinical response, remission, and endoscopic response at Weeks 12 and 40 using established disease activity scores. Researchers will monitor safety by tracking adverse events up to 4 weeks after the last dose. The study includes regular assessments through endoscopy, patient-reported outcomes, and laboratory tests to measure how the disease and treatment effects progress.

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 efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This Phase 3 program includes two separate studies with different treatment goals. Study 1 includes both induction and maintenance treatment and aims to see if tulisokibart doses are better than placebo in achieving clinical remission and endoscopic response at 12 and 52 weeks. Study 2 focuses only on induction treatment with similar goals measured at 12 weeks. Participants receive different dosing regimens of tulisokibart administered either intravenously IV or subcutaneously SC. Study 1 has groups receiving high or low dose IV tulisokibart followed by high or low dose SC tulisokibart maintenance, as well as placebo groups matching these routes. Study 2 includes induction treatment with high or low dose IV tulisokibart or placebo. Some participants may continue in extension arms with SC dosing after completing their initial study phase if they meet specific requirements. During the study, participants will be assessed regularly for clinical remission using Crohns Disease Activity Index scores or stool frequency and abdominal pain scores, and for endoscopic response by examination. These assessments occur at weeks 12 and 52 for Study 1 and at week 12 for Study 2. Researchers will monitor safety by tracking adverse events and treatment discontinuations. The total participation duration varies, with Study 1 lasting up to 52 weeks and Study 2 up to 12 weeks.

Researchers are evaluating the effects of etrasimod as a treatment for adults aged 18 to 65 with moderate to severe ulcerative colitis. This real-world, observational study aims to learn how etrasimod works when prescribed according to standard medical practice, with patients chosen if their doctor believes etrasimod is the best option. Participants should not have used etrasimod before joining the study. All patients will receive etrasimod as part of their routine care, and no changes to their treatment plan will be made for the study. The study lasts 52 weeks, followed by a 28-day safety follow-up. Patients will visit their doctors as usual and are asked to complete health questionnaires online regularly using their own mobile phone, tablet, or computer. During the study, researchers will compare each patients disease activity before and after starting etrasimod. They will review measures such as the proportion of patients achieving symptomatic remission at weeks 12 and 52, clinical response rates, and corticosteroid-free remission at week 52. Patients health status will be monitored through these questionnaires and routine medical visits throughout the study period.

This research aims to evaluate whether the medicine vicadrostat, combined with empagliflozin, helps adults who have chronic heart failure with a weakened heart pumping function, defined by a left ventricular ejection fraction under 40. Participants must have been diagnosed with chronic heart failure for at least three months and have symptoms classified as New York Heart Association class II to IV. The study is a Phase III trial conducted by Boehringer Ingelheim to assess the efficacy and safety of these medicines compared to placebo with empagliflozin. Participants are randomly assigned to one of two groups one group receives vicadrostat plus empagliflozin tablets, and the other group receives placebo tablets plus empagliflozin. Tablets are taken once daily for a period ranging from about six months up to approximately three and a half years. Participants continue their usual heart failure treatments during the study. The trial includes regular study visits and phone contacts to monitor health and treatment effects. During the study, participants will have their health regularly checked, including monitoring for worsening heart failure symptoms, hospitalizations, or death related to heart failure. They will also complete questionnaires about their well-being. The main measure is the time until the first cardiovascular death, hospitalization for heart failure, or urgent heart failure visit. Researchers will compare these outcomes between treatment groups to see if the combined treatment affects these events. Safety and any unwanted effects will be closely tracked throughout the study period, which can last up to about 3.5 years.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin can help adults aged 18 and older who have heart failure symptoms and a left ventricular ejection fraction LVEF of 40 or more. This phase III trial aims to assess the safety and effectiveness of this treatment compared to placebo with empagliflozin. Heart failure participants are classified as New York Heart Association NYHA class II-IV, and the study is sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once daily, while the other group takes placebo plus empagliflozin tablets once daily. The study is double-blind, meaning neither participants nor researchers know who is receiving which treatment. Participants remain in the trial as long as they benefit from and tolerate the treatment. Regular doctor visits and phone contacts monitor participants throughout the study. During the study, participants undergo regular health checks, including blood tests and questionnaires about well-being. Researchers track key health outcomes such as time to cardiovascular death, hospitalizations for heart failure, and quality of life measures using the Kansas City Cardiomyopathy Questionnaire. The study continues until sufficient data is collected, which may take up to 42 months. Safety and treatment effects are closely monitored throughout the trial.