This is a platform trial testing the addition of experimental treatments to standard of care (SoC) with three randomised controlled trials called research comparisons. The platform design allows the addition of other research treatments into the structure following protocol amendment. The primary objectives of each comparison are to test whether efficacy outcomes can be improved by the addition of the research treatments to SoC in men with metastatic prostate cancer and starting long-term androgen deprivation therapy. Key secondary objectives of each ...

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We are looking for new and better ways to manage melanoma, an aggressive type of skin cancer. Surgery to remove the melanoma will cure the majority of patients with early stage disease. However, a small percentage of these patients will go on to develop further disease, which may spread to other places in their body. At present, following surgery, patients with early stage melanoma can either choose to have close monitoring with regular scans and skin checks or they can ...

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We will use state-of-the-art imaging to look at heart disease in people with haemophilia. Haemophilia is an inherited disorder in which blood does not clot properly because of lack of a key ‘glue’ blood component (chemicals known as factor VIII or IX). People with haemophilia are 40% less likely to die of heart disease, but we don’t know why. Understanding heart disease in people with haemophilia is important because better treatments for haemophilia mean that these patients are now ...

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To evaluate the effect of AP01 100 mg given twice daily (BID) and AP01 50 mg BID compared to AP01 placebo (hereafter referred to as placebo) on lung function over 52 weeks in subjects with PPF B17: Secondary objective(s) To evaluate the effect of AP01 100 mg given twice daily (BID) and AP01 50 mg BID compared to AP01 placebo (hereafter referred to as placebo) on lung function over 52 weeks in subjects with PPF B18: Full inclusion criteria

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Cytomegalovirus (CMV), the international leading cause of neurodevelopmental impairment from infection acquired during pregnancy, is estimated to affect over 4200 babies and cost over £750 million each year in the UK. CMV is a common virus usually causing mild infection in healthy individuals, however CMV can cause serious disease if it affects a baby during pregnancy. Only the most severely affected cases of CMV acquired in pregnancy tend to be identified by healthcare professionals because there is currently no screening ...

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People with any condition that affects the liver over a long period of time can develop cirrhosis. Conditions that can lead to cirrhosis include alcohol excess, liver steatosis (lipid or fat accumulation in the liver) and infection with hepatitis B and C. One concern about people with cirrhosis is that they are at increased risk of developing liver cancer. People with cirrhosis are recommended to have an ultrasound scan (USS) every 6 months (surveillance) so that if a cancer develops, ...

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Our musculoskeletal system is essential for movement and to give our body structure. The system is made up of bones (skeleton) and soft connective tissues (muscles, tendons, cartilage and ligaments )that enable the skeleton to move. These tissues contain cells that work together to help the tissue function and grow normally. Our musculoskeletal system changes continuously from infancy to adulthood, with each tissue type changing in both size and shape, and they become less effective at repairing themselves when injured. Our ...

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A multi-centre, multi-national, prospective, randomized, placebo controlled, double blind clinical trial to investigate the efficacy and safety of BI 1819479 at three different doses (0.3 mg qw, 0.1 mg qd, 0.6 mg qd) in patients with IPF administered for at least 24 weeks and up to 52 weeks. The primary objectives are to demonstrate a non-flat dose response curve based on the annual rate of decline in FVC up to 52 weeks of treatments, using three different oral doses of BI ...

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This study is a randomized, controlled, dose-masked, multi-center study evaluating and comparing 2 doses of AGTC-501 to an untreated control group. A single subretinal injection of AGTC-501 (200 μL containing either 6.8 x 1011 vg per eye [high dose] or 3.7 x 1011 vg per eye [low dose]) will be administered to participants in 2 treatment groups (n = ~25 in each group). Once the primary analysis has been completed and the database has been frozen, participants in the untreated control ...

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There are Four treatment groups using a 1:1:1:1 ratio, who will receive a study treatment for 24 weeks. For intervention group amlitelimab + GF, they will have amlitelimab 500mg loading dose followed by a 250mg dose once every four weeks + gluten free products for the full 24 weeks. Intervention group placebo + Gluten free, will have matching placebo and gluten free products for the full 24 weeks. The amlitelimab + SIGE (simulated inadvertent gluten exposure) group, will have amlitelimab ...

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