Wakefield

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, both given alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease SSc-ILD. The study aims to assess how belimumab affects lung function, skin thickening, and symptoms like fatigue that influence quality of life in these patients. This is a Phase 23 randomized, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be randomly assigned to receive either belimumab or a placebo, both administered subcutaneously along with standard therapy. The treatment period lasts 52 weeks, during which the effects on lung function and skin symptoms will be closely monitored. The study involves two groups one receiving belimumab plus standard care and the other receiving placebo plus standard care. During the study, participants will undergo assessments including lung function tests such as Forced Vital Capacity FVC, skin thickness scoring, fatigue evaluations, and quality of life questionnaires at baseline and Week 52. Researchers will also track any adverse events and serious side effects. The main outcome measured is the change in lung function after 52 weeks. Participants will be monitored regularly throughout the 52-week treatment period to evaluate treatment effects and safety.

Researchers are studying the use of XEN1101 as an additional treatment for people aged 12 years and older who have primary generalized tonic-clonic seizures PGTCS associated with generalized epilepsy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the clinical effectiveness, safety, and tolerability of XEN1101 when added to existing anti-seizure medications. Participants are currently taking 1 to 3 anti-seizure medications and have had probable or possible PGTCS for at least one year. Participants will be randomly assigned to receive either XEN1101 or a placebo. Those aged 18 years and older will receive a 25 mg daily dose of XEN1101 or placebo. Participants aged 12 to under 18 years may receive 15 mg, 25 mg, or placebo daily. The study includes a baseline period lasting up to 9.5 weeks to track seizure frequency, followed by a 12-week double-blind treatment period where participants will take the assigned capsules once daily with an evening meal. After completing this period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week post-treatment follow-up if they do not enroll. During the study, participants will keep accurate seizure diaries and attend scheduled visits to monitor their health and response to treatment. Researchers will evaluate changes in monthly seizure frequency as the main outcome. Additional assessments will track safety, tolerability, and other measures throughout the treatment and follow-up periods. Overall participation may last several months, including baseline assessment, treatment, possible extension, and follow-up phases.

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, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the safety and effects of a medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. The study focuses on adults aged 18 to 70 who have had asthma for at least 12 months and have been on regular maintenance treatments. Asthma is a condition that makes breathing difficult and can reduce quality of life and daily functioning. Participants will receive either PF-07275315 or a placebo through multiple injections under the skin during clinic visits over a 12-week period. The study is randomized and blinded, meaning neither participants nor researchers know who receives the medicine or placebo. The trial includes several experimental groups receiving different doses of PF-07275315 and a group receiving placebo to compare safety and effects. The study includes a 12-week treatment phase. During about 7.5 months of involvement, participants will attend nine clinic visits. Researchers will monitor lung function using tests like forced expiratory volume in 1 second FEV1, record any side effects or adverse events, and assess asthma control and quality of life through questionnaires. Safety will be followed for 24 weeks, including lab tests, vital signs, and heart monitoring. This helps understand how PF-07275315 affects lung function and overall health in asthma patients.

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 investigating whether adding duroplasty, a surgical procedure that expands the tough membrane around the spinal cord, improves outcomes after severe cervical spinal cord injury. This trial focuses on adults with acute, severe injuries in the neck area who require surgery within 72 hours. The study aims to determine if duroplasty combined with standard bony decompression surgery enhances muscle strength and functional recovery compared to bony decompression alone. Participants will be randomly assigned to receive either standard spinal surgery including laminectomy alone or the same surgery plus duroplasty. Some patients may also join an optional mechanistic sub-study where probes and microdialysis catheters monitor spinal cord pressure, blood flow, metabolism, and inflammation at the injury site. The study will recruit around 222 to 260 patients over four years, including sites in the UK and internationally. During the study, participants will be assessed at baseline, 3, 6, and 12 months after surgery using questionnaires and physical examinations to measure muscle strength, hand function, walking ability, bladder and bowel control, and quality of life. Some will have MRI scans at 2 weeks and 6 months, and safety outcomes such as complications, additional surgeries, and mortality will be tracked up to 12 months. Follow-up lasts one year to evaluate recovery and treatment impact.