Valladolid

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are evaluating treatments for participants with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. This Phase 3 study compares if the combination of belantamab mafodotin, lenalidomide, and dexamethasone (BRd) can extend progression-free survival or increase the number of participants achieving minimal residual disease negative status compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd). Participants will receive either BRd or DRd treatment. Belantamab mafodotin, lenalidomide, and dexamethasone will be administered in the BRd group, while daratumumab, lenalidomide, and dexamethasone will be given in the DRd group. The study will monitor participants over approximately 7 years to assess long-term outcomes. During the study, participants will undergo assessments to measure progression-free survival and minimal residual disease status. Researchers will collect clinical data, laboratory tests, and safety information throughout the treatment and follow-up periods. The total duration of participation may last up to about 7 years to evaluate long-term effects and outcomes of the treatments.

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, tolerability, pharmacokinetics, pharmacodynamics, and immune response to the drug GSK4527363. The study is a Phase 1 trial involving healthy participants, people with active Systemic Lupus Erythematosus (SLE), healthy individuals of Chinese and Japanese descent, and participants with interstitial lung disease linked to connective tissue disease. The trial aims to gather detailed safety and biological data across these groups. Participants will receive either GSK4527363, a matching placebo, or Belimumab. The study is divided into four parts: Part A includes healthy participants; Part B involves those with active SLE; Part C focuses on healthy participants of Chinese and Japanese ancestry; and Part D enrolls participants with connective tissue disease-associated interstitial lung disease. Treatments are administered according to group assignments, with monitoring continuing up to 52 weeks for Parts A and C and up to 68 weeks for Parts B and D. During the study, researchers will monitor participants closely through physical exams, laboratory tests, vital signs, and heart monitoring. Safety assessments include tracking adverse events and changes in mental health using specific rating scales. Participants are observed for up to 52 or 68 weeks depending on their group, with regular check-ins to evaluate the study drug's effects and ensure participant safety throughout the trial.

Researchers are evaluating the safety and effectiveness of orforglipron, taken once daily, in people who are overweight or have obesity and also suffer from knee osteoarthritis with pain. This phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to understand how well orforglipron works over about 74 weeks. The study is part of a larger master protocol supporting two independent studies focused on this condition and population. Participants will receive either orforglipron or a placebo, both administered orally. The study compares these two groups in a parallel-arm design to assess treatment effects. The trial includes a long treatment and observation period lasting about 74 weeks to monitor changes and safety outcomes. Throughout the study, participants will be assessed for changes in their knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, measured at the start and at week 72. Researchers will also monitor the participants' safety and overall health during the trial. The participation duration is approximately 74 weeks, including screening, treatment, and follow-up visits.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effectiveness, safety, and patient-reported outcomes of standard treatments for people with relapsed or refractory multiple myeloma in real-world clinical settings. This study follows participants over 24 months to observe how current standard care works for those who have previously received treatment for this condition. The research includes participants who meet specific diagnostic criteria and have measurable disease based on recognized myeloma guidelines. The study does not involve any experimental treatment; instead, it observes patients receiving standard care as decided by their doctors. Participants include those who have undergone multiple prior therapies, including specific drug classes and targeted treatments, depending on the study period. The study covers different periods with slightly varied eligibility and treatment histories, including a group starting talquetamab treatment for relapsed or refractory multiple myeloma. Participants will be monitored for up to 52 months to evaluate their response to treatment, including overall response rates. Researchers will collect data on their health status, treatment history, and patient-reported outcomes. Safety and effectiveness will be assessed based on clinical evaluations and disease progression as determined by their healthcare providers throughout the study period.

Researchers are evaluating the safety and effectiveness of KarXT in preventing relapse of psychosis symptoms in people aged 55 to 90 years who have psychosis associated with Alzheimer's Disease. This Phase 3 study is randomized, double-blind, placebo-controlled, and conducted at multiple outpatient centers. The main goal is to compare relapse prevention between KarXT treatment and placebo over 38 weeks, while also assessing time to discontinuation, safety, and tolerability. Participants receive either KarXT in varying doses (ranging from 20 mg/2 mg to 66.7 mg/6.67 mg taken three times daily) or placebo capsules. The study lasts 38 weeks, during which participants remain on assigned treatment in an outpatient setting. The randomized, double-blind design ensures neither participants nor researchers know who receives KarXT or placebo during the study. Throughout the study, participants will visit the clinic regularly for assessments of their psychosis symptoms, safety checks, and overall health. Researchers will track the time to relapse of psychosis symptoms as the primary outcome. They will also monitor safety and tolerability through clinical examinations and other evaluations. The total duration of participation is 38 weeks from randomization to the end of the study period.