North Shields

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 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 safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase 3 study includes participants who have had at least two moderate or one severe COPD exacerbations in the past year despite inhaled maintenance therapy. The goal is to better understand if tezepelumab can reduce the rate of COPD exacerbations and improve lung function and quality of life. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo for a treatment period lasting between 52 and 76 weeks. After the treatment phase, there is a 12-week off-treatment safety follow-up. The study is randomized, double-blind, and placebo-controlled, ensuring that neither participants nor researchers know who receives the active medication or placebo. During the study, participants will have regular assessments including lung function tests, questionnaires about respiratory health and symptoms, and blood samples to measure drug levels and immune response. Researchers will track COPD exacerbation frequency, lung function changes, and symptom improvements. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods, with total participation lasting up to approximately 88 weeks.

Researchers are evaluating the long-term safety and tolerability of pelacarsen TQJ230 in adults with established cardiovascular disease and elevated Lipoproteina who have completed a prior double-blind study. This open-label extension study follows participants from the parent trial CTQJ230A12301 to continue monitoring the effects of pelacarsen over an extended period. Participants will receive pelacarsen 80 mg once a month by subcutaneous injection during the open-label extension. This single-arm, multicenter study lasts up to 36 months, providing continued access to the study drug for those who completed the parent trial while still on the investigational product. During the study, participants will be regularly assessed for adverse events and cardiovascular outcomes, including major cardiovascular events tracked from both the parent study baseline and the extension study baseline. Lipoproteina levels will be measured at multiple time points to monitor changes over the course of the study. Safety and tolerability data will be collected up to 36 months, with ongoing monitoring by the research team throughout the study duration.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

Researchers are evaluating the effect of tozorakimab as an addition to standard care in adults hospitalized with viral lung infections who require supplemental oxygen. The goal is to see if tozorakimab can help prevent death or the need for invasive mechanical ventilation or extracorporeal membrane oxygenation ECMO. This is a Phase III, randomized, double-blind, placebo-controlled study sponsored by AstraZeneca. Participants will be randomly assigned in equal numbers to receive either a single intravenous dose of tozorakimab or a matching placebo on Day 1. About 2870 participants will take part, with approximately 1435 in each group. This treatment is given once, and participants are monitored for outcomes related to lung infection and respiratory failure. During the study, researchers will assess how many participants die or need advanced breathing support by Day 28, along with several other outcomes tracked up to Day 60. Assessments include survival, time spent outside the ICU, time without supplemental oxygen or ventilation, and clinical progression scales. The study includes safety monitoring and measures of immune response. Participation involves hospitalization and follow-up assessments over at least 60 days from treatment.

Researchers are investigating factors linked to low blood eosinophil counts eosinopenia in patients hospitalized with severe flare-ups of chronic obstructive pulmonary disease COPD. They aim to identify what influences eosinopenia on admission and to find out how long it takes for eosinophil levels to return to normal after such severe episodes. This observational study focuses on understanding these patterns to help guide treatment decisions, particularly regarding inhaled corticosteroids ICS. The study observes patients admitted with severe COPD exacerbations and measures their blood eosinophil counts over time. Participants are grouped based on whether their eosinophil counts are low or normal at admission. Blood samples and clinical data are collected at admission and repeatedly over six weeks to monitor recovery of eosinophil counts to a stable baseline. Researchers examine various clinical and physiological factors related to eosinopenia and its recovery. During the study, participants undergo blood tests, clinical assessments, and monitoring of their health status at admission, and at 1, 2, 3, 4, and 6 weeks afterward. The main outcomes include identifying factors associated with low eosinophil counts at admission and measuring the time needed for eosinophil levels to recover. Secondary analyses look at changes in immune markers, comparison with past exacerbations, and the influence of new exacerbations on eosinophil recovery. The total participation duration varies per participant but includes follow-up through six weeks post-admission.

Dementia affects millions worldwide, and early diagnosis is crucial for proper care and support. Doctors often rely on information from family members or caregivers to understand changes in memory and thinking, but this information can be incomplete or hard to get. This research is testing LUMEN, an AI-powered conversation tool designed to help caregivers provide clearer, more organized reports about symptoms, aiming to improve dementia assessment accuracy and reduce caregiver stress. LUMEN is a prototype software that guides caregivers through structured questions on a laptop or tablet, creating detailed histories before clinical assessments. The study involves caregivers and patients attending memory clinics, along with dementia specialists who review the AI-generated reports. The research includes usability testing using questionnaires, qualitative interviews, and community workshops to ensure the tool is accessible across diverse backgrounds. Participants will provide baseline information, use LUMEN for about 20-30 minutes, and complete assessments measuring ease of use and mental effort. Caregivers and clinicians will be interviewed to gather feedback. The study runs for 12 months and aims to understand how well LUMEN fits into clinic workflows and its potential to improve dementia diagnosis and caregiver experience.