East Kilbride

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 whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

Researchers are studying patients with known or suspected angina who do not have obstructive coronary artery disease to see if a special diagnostic test can help guide personalized treatment. This condition includes ischaemic heart disease, microvascular angina, and vasospastic angina. The trial builds on earlier research suggesting that tailoring treatment based on coronary vascular function tests may improve symptoms and quality of life. This large, multicentre, blinded, randomized study aims to confirm these findings and assess effects on health and wellbeing over a longer period. Participants undergo invasive coronary angiography along with an adjunctive interventional diagnostic procedure (IDP) that measures coronary vascular function using a guidewire technique. Patients with no significant artery blockage are randomized into two groups: one where IDP results are disclosed to guide treatment decisions, and a control group with concealed results receiving standard care. Those with abnormal vascular function in the intervention group may have repeated assessments to tailor medications, such as calcium channel blockers. Patients with obstructive artery disease or other exclusions may join a registry for follow-up and assessment. Throughout the study, participants complete questionnaires about angina symptoms, quality of life, activity levels, treatment satisfaction, and pain. Researchers monitor clinical outcomes for at least 12 months, including major cardiovascular events. The study also evaluates the safety and usefulness of the diagnostic procedure in multiple hospitals across Europe. Blood samples are collected to explore disease mechanisms. Participants and their doctors remain blinded to group assignments, but diagnoses are shared to help guide care following current guidelines.

Researchers are investigating the use of Magnetic Resonance Tumour Regression Grade (mrTRG) as a new imaging biomarker to guide treatment decisions in patients with locally advanced rectal cancer. This phase III trial in the UK is unique in offering a 'watch and wait' approach for patients who respond well to pre-operative treatment, potentially avoiding surgery and preserving quality of life. The study aims to validate mrTRG to differentiate between good and poor responders to radiotherapy and help tailor ongoing treatment and surveillance accordingly. Participants will be randomly assigned to one of two groups. The control group will receive standard management based on national guidelines and clinical assessments after treatment, including routine MRI scans without mrTRG reporting. The intervention group will have post-treatment MRI scans evaluated by specially trained radiologists to assess mrTRG grades. Patients classified as good responders (mrTRG 1 or 2) will be offered a watch and wait approach to avoid surgery, while poor responders (mrTRG 3 to 5) will have their cases reviewed by a local colorectal multidisciplinary team for further treatment planning. During the study, all participants will undergo routine MRI scans following standardized protocols and complete quality of life questionnaires at registration, 3 years, and 5 years. Researchers will monitor outcomes for up to five years, focusing on whether surgery can be safely avoided in good responders and tracking long-term effects on health and survival. The study does not mandate specific chemotherapy or investigational treatments, allowing local teams to decide additional therapy as needed.

Researchers are investigating the use of eplerenone, a mineralocorticoid receptor antagonist, in patients who have had a heart attack or heart injury but do not have blockages in their large coronary arteries. The study focuses on those with damage to the small blood vessels (coronary microvascular dysfunction), which can cause heart problems. This Phase 2 trial aims to better understand and treat this condition, which currently lacks specific therapies, by identifying patient subgroups and evaluating targeted treatment effects. Participants will first undergo a coronary angiogram and a diagnostic guidewire test to measure small vessel function. Based on these results, patients are divided into three groups: those without microvascular dysfunction receiving no eplerenone, those with dysfunction receiving standard care without eplerenone, and those with dysfunction randomized to receive eplerenone tablets. The eplerenone dosage starts at 25 mg daily and may increase to 50 mg after two weeks, continuing for six months. Cardiac MRI scans and other diagnostic tests are used to assess heart function and damage. During the study, participants will have blood tests at enrollment, one month, and six months to monitor heart injury biomarkers like NT-proBNP. Questionnaires about health status and long-term health data including hospitalizations and mortality will also be collected. The study includes up to 20 years of follow-up through electronic health records. Additionally, some participants may join a brain MRI substudy to assess related small vessel disease. The study plans to store blood samples for future research and aims to advance knowledge about eplerenone treatment in this patient group.

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant (ASCT). This phase III, open-label, randomized, controlled study aims to evaluate whether adding a proteasome inhibitor to the salvage ASCT conditioning improves the depth of response, and to assess the impact of consolidation and maintenance treatments on the durability of response. The study also looks at overall survival, progression time, quality of life, and treatment safety among participants with measurable disease and good performance status. All participants first receive re-induction therapy consisting of 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone (ITD) over 28-day cycles to achieve maximum disease control. Those who reach stable disease or better are randomized to receive either conventional ASCT using melphalan or augmented ASCT combining melphalan with ixazomib. Following this, participants who maintain minimal response or better undergo a second randomization to either receive consolidation therapy with 2 cycles of ITD followed by ixazomib maintenance until disease progression, or no further treatment. During the study, participants will undergo regular assessments including blood tests, disease response evaluations, and monitoring for adverse effects. The primary outcomes measured are overall response rate 100 days after ASCT and progression-free survival up to 10 years. Secondary evaluations include overall survival, time to disease progression, minimal residual disease status at various stages, engraftment kinetics, and quality of life. Follow-up continues with clinic visits every three months until disease progression is observed, enabling long-term monitoring of treatment effects and safety.