This Phase III, multi-center, open-label, sponsor-blinded, randomized study is designed to evaluate the efficacy and safety of AZD0901 compared to Investigator’s choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2, and the clinical performance of the investigational IVD. As part of this combined approach, t he efficacy analyses from this study will also provide the basis to evaluate the clinical performance of Ventana CLDN18.2 (SP455) IHC assay (prototype assay and/or validated assay ...

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In 2016, 11,563 women died from breast cancer in the UK. Most would have been prescribed hormone therapy (HT); sometimes known as endocrine therapy, which blocks the effect of oestrogen on breast cancer cells. HT is prescribed as a daily tablet, usually for at least five years and often up to 10 years. When women stop taking HT prematurely, or don’t take it as prescribed (known as “poor adherence”), they have up to a three times higher chance of the ...

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BI 690517 is an aldosterone synthase inhibitor and participants will be randomised 1:1 (using a minimisation algorithm) to active of placebo BI 690517 in addition to study supplied empagliflozin 10mg daily.

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This protocol includes 2 independent, multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2) to assess the efficacy and safety of MK 7240 in participants of any sex/gender aged 16 to 75 (inclusive) with moderately to severely active CD. While this “master” protocol includes common operational elements for both Study 1 and Study 2, randomization, data collection, statistical analyses, and data reporting will be conducted for each study independently. Each study has its own objectives and ...

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Approximately 420 eligible participants will be randomized in a 1:1 ratio to aficamten or placebo. Doses of 5, 10, 15, or 20 mg aficamten or matching placebo will be administered in an escalating manner using echocardiography to guide dose titration. Randomization will be stratified by persistent atrial fibrillation and presence of intracavitary obstruction. The study will consist of 2 parts: Part 1 will be comprised of Day 1 to Week 36 and Part 2 will be comprised of Week 36 to ...

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This is a global, multicenter, randomized, open-label, Phase 2/3 study in subjects with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. In this operationally seamless design, data from Phase 2 will not be utilized for the primary analysis in Phase 3 to strictly control the type I error in Phase 3. Phase 2 Study Design The Phase 2 part of this study is designed ...

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Behçet's disease (BD) is an inflammatory condition that causes damages of the blood vessels affecting many parts of the body. The disease is characterized by intermittent symptoms of varying severity across almost all organ systems and oral ulcers, considered the most common sign at the onset of BD and are observed in nearly every patient The treatment of BD is generally based on experience, and the drug of choice is based on specific clinical signs and symptoms in each patient. The ...

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This is a multicentre, prospective, non-interventional observational cohort study of patients who are planned to receive, or already receiving Epidyolex under real-world conditions of clinical care. This study is designed to address a Pharmacovigilance Risk Assessment Committee (PRAC) request to conduct a Category 3 Post-Authorisation Safety Study (PASS), as requested in the Risk Management Plan (RMP) at the time of approval. While 12 safety concerns were noted in the RMP, PRAC emphasis was on the need to further characterize the ...

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This study will evaluate the expression of neurofilaments and of other relevant molecules in blood samples taken from individuals with amyotrophic lateral sclerosis at different time points during the development of the disease. Our aim is to validate easily accessible disease biomarkers functioning as reliable predictors of disease severity and capable of providing information about the stratification of the disease phenotypes. Control groups will include healthy individuals and patients with a compressive radiculopathy. Recruitment will take place in 4 motor ...

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The study hypothesis is that a strategy of universal primary prevention of anaemia during pregnancy with oral iron supplementation will impact the composite primary outcome of pre-term birth,stillbirth,neonatal death and small for gestational age (SGA).

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