Bath

Researchers are studying a treatment called MK-2214 to see if it can slow certain brain changes in people with early Alzheimer's disease (AD). AD is a form of dementia that causes memory loss, difficulties with communication, and challenges in decision-making, which affect daily activities. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the safety and tolerability of MK-2214. Participants will receive either MK-2214 or a placebo through an intravenous (IV) infusion. The study is designed as a phase 2, randomized, placebo-controlled, double-blind trial with parallel groups. The treatment period lasts up to about 23 months, during which participants will receive infusions as scheduled. The placebo looks like the study treatment but contains no active drug, helping researchers understand the treatment's effects. Throughout the study, participants will be monitored for changes in tau protein levels in the brain using PET scans and for any adverse events or side effects. Researchers will track the number of participants experiencing adverse events and those who stop treatment because of them, with safety follow-up lasting up to approximately 26 months. Participants will also undergo brain imaging such as CT, PET, or MRI scans. The study involves regular assessments to measure the treatment's impact and ensure participant safety over the study duration.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating the effectiveness and safety of zanidatamab combined with a physician's choice of chemotherapy compared to trastuzumab combined with chemotherapy in treating adults with metastatic HER2-positive breast cancer. This study focuses on participants whose cancer has progressed or who cannot tolerate previous treatment with trastuzumab deruxtecan (T-DXd). The study is a phase 3 randomized trial aiming to assess progression-free survival and other important outcomes such as patient-reported tolerability and physical functioning. Participants receive either zanidatamab or trastuzumab through intravenous infusion, alongside chemotherapy drugs chosen by their physician from eribulin, gemcitabine, vinorelbine (all intravenous), or oral capecitabine. The study includes detailed monitoring of drug safety and how the body processes zanidatamab. The treatments continue until disease progression or unacceptable side effects occur. During the study, participants undergo regular evaluations including scans to measure cancer progression according to RECIST guidelines. Researchers also monitor safety through laboratory tests and heart function assessments. Participants are followed for up to approximately 44 months to measure progression-free survival and overall treatment outcomes. Long-term follow-up and patient-reported outcomes help provide a complete understanding of the treatments' effects.

Researchers are assessing the effectiveness and safety of current standard treatments in people with active systemic lupus erythematosus (SLE), including lupus nephritis, who have not adequately responded to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with active disease despite treatment, aiming to better understand outcomes in this group. Participants receive standard care treatments based on product labels, which include glucocorticoids and immunosuppressants, with at least one biologic therapy used for a minimum of three months. The study includes those with lupus nephritis confirmed by recent kidney biopsy showing specific active disease features. Treatment follows usual clinical practice without experimental therapies. During the study, participants will be monitored for disease remission using established lupus criteria at six months. Researchers will collect routine clinical data and track safety and response to treatments. The study requires participants to be at least 16 years old and to provide informed consent. Pregnant women and those involved in other experimental drug trials are excluded. The study involves ongoing clinical follow-up to evaluate outcomes over time.

Researchers are studying the clinical and health-related outcomes of treatments containing amivantamab for people with common EGFR-mutated advanced non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. This type of cancer can spread to other parts of the body and occurs due to changes in genes such as the epidermal growth factor receptor (EGFR). The study focuses on real-world use of these treatments outside of controlled clinical trials. Participants will receive amivantamab-containing regimens as part of their standard care, decided by their doctors according to approved guidelines and local recommendations for supportive medications. The study observes patients starting these treatments for the first time and follows their clinical course as they receive care in usual medical settings. During the study, researchers will collect data for up to approximately 60 months to understand how long patients continue treatment and other health outcomes. Data collection includes monitoring treatment use, clinical responses, and safety in a real-world context. Participants or their representatives must provide consent for data verification, and the study tracks outcomes during routine clinical visits without altering standard treatment practices.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes two parts: Phase 2 to find the best dose based on safety and response, and Phase 3 to compare R-DXd with the investigator's choice of chemotherapy. R-DXd is an antibody-drug conjugate that targets CDH6, a protein overexpressed in tumor cells. Participants will receive R-DXd through intravenous infusions. In Phase 2 (Part A), the dose will be optimized, and biopsies will be collected before and during treatment if possible. In Phase 3 (Part B), participants will be randomly assigned to receive either R-DXd or chemotherapy chosen by their doctor, which may include paclitaxel, topotecan, or PLD, all given by IV infusion. The study monitors treatment effects up to 18 months in Phase 2 and up to 26 months in Phase 3. During the study, participants will have regular scans and assessments to measure tumor response and progression-free survival. Researchers will monitor safety and organ function through lab tests and performance status evaluations. Participants must be willing to follow the study visits and procedures, which include biopsy samples in Phase 2 and imaging assessments to evaluate treatment response. The study aims to provide detailed information about how well R-DXd works and its safety in this patient group.

Researchers are evaluating Tulmimetostat, a drug given alone, to assess its safety, tolerability, and early effectiveness in adults with advanced solid tumors and lymphomas. This open-label trial includes patients whose cancers have progressed after standard treatments or who have no effective standard therapy options. The study includes Phase 1 dose escalation to find the best dose and Phase 2 to further assess safety and anti-tumor activity in specific cancer types, including several cohorts with different tumor types and genetic markers. Participants receive Tulmimetostat orally once daily in 28-day cycles. Phase 1 determines the maximum tolerated dose and recommended Phase 2 dose. Phase 2 includes six disease-specific cohorts (M1 to M6) with 10 to 29 patients each, using a Simon 2-stage design. Some cohorts include randomized stages comparing two dose levels. Additional cohorts (M7 and M8) study Tulmimetostat effects in endometrial carcinoma and in combination with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC). In Cohort M8, Part 1 tests dose escalation of Tulmimetostat plus enzalutamide, while Part 2 evaluates safety and preliminary activity at the recommended dose. Throughout the study, participants undergo regular assessments including imaging to measure tumor response, safety evaluations, and monitoring of side effects. Dose-limiting toxicities are assessed during the first 28-day cycle in Phase 1 and Cohort M8 Part 1. Overall response rates are evaluated up to 30 months in Phase 2 and Cohort M8 Part 2. Participants must have a good performance status and adequate organ function. The study monitors treatment effects, safety, and tolerability over time to understand Tulmimetostat’s potential in these cancers.

Researchers are evaluating the ability of dapirolizumab pegol (DZP) added to standard care medications to improve moderate to severe systemic lupus erythematosus (SLE) symptoms over the long term. This Phase 3 trial focuses on participants aged 16 and older who have active SLE with specific disease activity and serological markers. The goal is to assess clinical improvement using the British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) at Week 48. Participants will be randomly assigned to receive either dapirolizumab pegol (DZP) or placebo at scheduled times alongside their stable standard of care treatments. Standard medications include antimalarials combined with glucocorticoids and/or immunosuppressants or glucocorticoids and/or immunosuppressants alone if antimalarials are not suitable. The study is double-blind and placebo-controlled, ensuring unbiased comparison between the two groups. Throughout the study, participants will undergo regular assessments to monitor disease activity and treatment safety up to Week 48. Researchers will track responses based on disease activity indices and monitor for any adverse effects. The study includes careful screening and follow-up evaluations to understand the long-term effects of adding DZP to usual care in people with moderately to severely active SLE.

Researchers are investigating the effects of teplizumab compared with a placebo in children and young adults aged 1 to 25 years who have recently been diagnosed with Stage 3 type 1 diabetes (T1D). This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess changes in blood sugar control and dependence on prandial insulin over one year. The study follows established criteria for Stage 3 T1D diagnosis and includes participants on standard insulin therapy. Participants will receive either teplizumab or placebo through intravenous infusion. Both treatments are given as a solution for injection. The study spans approximately 84 weeks (18 months) for each participant, with the main treatment period lasting 52 weeks. The trial compares the effects of the two treatments on diabetes management and insulin use over this time. During the study, participants will undergo evaluations of their blood sugar control, including measurements of glycated hemoglobin (HbA1c) and insulin use. For those in European Union countries aged 5 years and older, additional tests will measure insulin production response after a meal. Safety and health will be monitored through regular clinical assessments, lab tests, and antibody screening. The study tracks changes from the beginning through the 52-week treatment period to understand the impact of teplizumab on diabetes progression.