DV0013 is a Phase 3b, multicenter, open-label study to evaluate the safe and effective use of a ZLP-AI combination product for sc self-administration of ZLP solution (the IMP) by study participants with generalized myasthenia gravis (gMG), planned to be conducted in Europe and the US. The study will aim to reflect real-world use scenarios by including participants who are already self-administering ZLP using the PFS on a once-daily dosing regimen as part of the MG0011 long-term open-label extension (OLE) study or ...

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Telehealth in MND (TiM) is a remote monitoring system for people with MND (pwMND) and their carers, who complete regular questionnaires through the system, which are reviewed by healthcare professionals (HCPs). We also have funding to develop a research-specific TiM system. Therefore, the current service is called TiM-Care and the new system is called TiM-Research. This project aims to develop and evaluate the two systems. The project is split into four parts. Firstly, implementing new digital services into the NHS is ...

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The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7-CMS. The study will also assess how ARGX-119 is processed by the body (PK), how the immune system reacts to it (immunogenicity), and how it may improve the way patients feel and function. This phase 1b, multicenter, randomized, double-blinded, placebo-controlled study is designed to assess the safety, tolerability, PK, immunogenicity, and preliminary efficacy of ARGX-119 in participants with DOK7-CMS. Eligible participants will be aged ...

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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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This is a Phase 2, nonrandomized, single-arm, multisite, open-label study of the PK, efficacy, and safety of MK-3475A SC in adult participants with rrcHL or rrPMBCL. Participants must be anti-PD-1 and anti-PD-L1/PD-L2 naïve. Participants with rrcHL (Cohort 1) must have failed to respond or relapsed after at least 1 line of multiagent therapy (chemotherapy with or without BV), or did not achieve CR or relapsed after an auto-SCT, or are ineligible for auto-SCT. Participants with rrPMBCL (Cohort 2) must have failed to ...

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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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Bowel cancer is one of the leading causes of cancer-related deaths worldwide. In the early stages of the disease, many patients can be cured with surgery. However, in the later stages, bowel cancer can return or progress even after surgery and chemotherapy. One potential way of preventing relapse is by making the patient’s immune system better at detecting and destroying any cancer cells that might remain after treatment. T cells are a type of white blood cell that play a ...

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All patients who are diagnosed with womb, bowel, or ovary cancer are recommended to have genetic-testing to see if their cancer was related to an inherited gene alteration. Identifying carriers of alterations allows novel personalised cancer treatments, prevention of second cancers, and testing of family members for cancer screening and prevention. Genetic testing requires pre-test counselling to ensure patients are informed about the impact of having a genetic test and managing the result. This ‘genetic-counselling’ has traditionally been provided by genetics ...

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This is a global, multicenter, randomized, open-label, Phase 3 study designed to compare the efficacy and safety of I-DXd with the TPC in subjects with relapsed SCLC. Eligible subjects will have received one prior line of platinum-based therapy and at least 75% of whom will have received prior treatment with anti-programmed death-(ligand) 1 (PD-[L]1) antibody. Subjects must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤1. This study is designed to randomize at least 468 subjects in a ...

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This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm study to investigate the efficacy and safety of SC injections of amlitelimab as monotherapy in participants aged 12 years and older with severe AA. At the end of the treatment period, all participants will have the option to enter a separate study, the open label extension study. The study duration will be up to 44 weeks for participants not entering the open extension study including a 2 to 4-week screening, ...

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