Ballinasloe

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.

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 whether follow-up care through virtual wards can reduce hospital admissions for heart failure patients within three months after discharge. The study includes adults over 18 years old who were recently hospitalized for worsening heart failure. The trial also aims to see if this approach lowers death rates, reduces overall hospital stays, improves medication use and dosing, enhances quality of life, and is cost-effective. Longer-term effects at six and twelve months will be checked through telephone or virtual outpatient visits. Clinical events will be reviewed by a committee unaware of patient group assignments to ensure unbiased results. Participants will be randomly assigned to either usual care or telemedicine follow-up groups. Those in the telemedicine group will receive a tablet (if they do not already have one), a weight scale, and a blood pressure monitor. They will record daily biometric data including weight, heart rate, and blood pressure, along with answers to four symptom questions to monitor heart condition changes. The usual care group will have a face-to-face appointment within two weeks after discharge and follow-up visits at 6 and 12 weeks, following heart failure treatment guidelines. During the study, participants will have scheduled visits to assess outcomes and provide ongoing care. Researchers will monitor hospital readmission rates, overall mortality, hospitalization frequency, medication prescription and dosing, and quality of life measures. Safety and clinical events will be followed up at three, six, and twelve months. Total participation duration includes initial hospitalization recovery and follow-up through virtual or in-person visits, with careful oversight to track the study's impact on heart failure management.

Researchers are evaluating the effectiveness and safety of benralizumab as an additional treatment for people aged 12 to 75 with uncontrolled eosinophilic asthma who are already using medium-dose inhaled corticosteroids combined with long-acting beta2-agonists (ICS-LABA). The study compares this approach to the usual care of increasing inhaled therapy to high-dose ICS-LABA. This is a global, phase 3b, randomized, double-blind, active-controlled trial involving participants with a history of eosinophilic asthma. Participants receive either benralizumab 30 mg by subcutaneous injection every 4 weeks for the first three doses and then every 8 weeks, alongside their medium-dose ICS-LABA treatment, or they receive a placebo injection with an increased high-dose ICS-LABA treatment. The study includes a run-in period to monitor compliance with usual asthma treatment and aims to assess adding benralizumab versus stepping up inhaled therapy. During the study, researchers monitor asthma control, lung function, and exacerbations over 48 weeks. Participants complete asthma diaries to track medication adherence and symptoms. The main outcome measured is the annual rate of asthma exacerbations. Safety and adverse events are also closely followed throughout the study period.

Researchers are evaluating targeted therapies for adult participants with moderate to severe Crohn's disease, a chronic condition causing severe inflammation in the digestive tract. This disease often leads to symptoms like belly pain, diarrhea, tiredness, and weight loss. The study aims to assess the effectiveness and side effects of several targeted treatments, as current therapies may not work equally well for all patients or may lose effectiveness over time. This is a Phase 2a multicenter, randomized platform study enrolling around 540 adults across approximately 300 sites worldwide. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These therapies are administered either as injections under the skin or infusions into the vein, depending on the drug. Participants will be randomly assigned to one of the treatment groups. The study will involve regular visits to hospitals or clinics where participants receive their assigned treatments and are monitored throughout the study period. Participants will undergo medical assessments including blood tests and endoscopies to check the status of their disease and to monitor for any side effects. They will also complete questionnaires and keep a daily diary to track their condition. The main outcome measured is the percentage of participants who achieve endoscopic remission by week 12. The study involves careful safety monitoring and aims to provide detailed data on the treatments over the course of the trial.