Woodville

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.

This research aims to evaluate the safety and effectiveness of BMS-986504, a selective PRMT5 inhibitor, when combined with Nab-paclitaxel and Gemcitabine, compared to a placebo combined with Nab-paclitaxel and Gemcitabine. The study focuses on participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) who have a specific genetic alteration called homozygous MTAP deletion. This is a randomized Phase 2/3 trial designed to explore treatment options for this patient population. Participants will be assigned to receive either BMS-986504 at specified doses on certain days along with Nab-paclitaxel and Gemcitabine, or a placebo with the same chemotherapy drugs. The treatments are given according to protocol schedules. Some participants may have received up to one cycle of Nab-paclitaxel and Gemcitabine before starting the study treatment, provided they did not experience disease progression or intolerable side effects. The initial cycle must be completed before randomization. During the study, researchers will monitor participants for progression-free survival and overall survival for up to three years after the last participant is randomized. Assessments include measuring tumor response using established criteria (RECIST v1.1). Participants will undergo evaluations to track safety, treatment effects, and disease status throughout the trial period.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational drug INI-822 in healthy adults and participants with non-alcoholic steatohepatitis (NASH) or presumed NASH. This Phase 1 clinical trial includes multiple parts to assess single and multiple ascending doses of INI-822 and to study its effects in both healthy volunteers and those with a history of NASH. The study is divided into four parts: Part A enrolls about 48 healthy adults across six cohorts, including one fasted-fed crossover group to study the food effect. Part B includes 24 healthy adults in three cohorts receiving multiple ascending doses. Part C enrolls 24 participants with NASH or presumed NASH in two cohorts to evaluate pharmacodynamics. Part D involves 8 healthy adults in a single cohort for single ascending dose assessment. Participants receive either different doses of INI-822 or matching placebo. Participants will attend study visits for dosing, monitoring, and assessments throughout study periods lasting up to 9 weeks depending on the part. Researchers will monitor adverse events, clinical laboratory results, and pharmacokinetic parameters. Safety evaluations include physical exams, vital signs, ECGs, and laboratory tests. The study aims to understand the drug's safety profile and how it behaves in the body in both healthy individuals and those with NASH.

Researchers are evaluating new combination treatments for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) in this Phase II, multi-center, open-label study. The trial includes several sub-studies focusing on different groups of NSCLC patients based on genetic and protein markers. The goal is to study the safety, tolerability, and early anti-tumor effects of these novel treatment combinations across about 80 centers worldwide in 10 countries. The study consists of three sub-studies: one testing rilvegostomig with or without ramucirumab in patients with high PD-L1 expression (50% or more) and no actionable genomic alterations; another testing rilvegostomig plus ramucirumab in patients with moderate PD-L1 expression (1-49%) and no actionable genomic alterations; and a third testing Dato-DXd with ramucirumab, with or without rilvegostomig, in later-line patients positive for actionable genomic alterations who have progressed on prior targeted therapy. Treatments are given by intravenous infusion. Each sub-study may have two parts: a safety run-in phase and a dose expansion phase. Participants will be involved for around 3 years, during which researchers will monitor adverse events and serious adverse events to assess safety. They will also evaluate the objective response rate to measure anti-tumor activity. Participants must have adequate organ function, a certain performance status, and measurable tumors. Regular assessments include tumor tissue analysis and monitoring of health status. The study excludes those with certain infections, uncontrolled diseases, or prior therapies that could interfere with the trial.

This research aims to evaluate the safety and effectiveness of belimumab in adults with interstitial lung disease (ILD) related to connective tissue diseases (CTDs) such as rheumatoid arthritis, lupus, and others. ILD causes lung inflammation and stiffness, reducing lung volume and leading to symptoms like shortness of breath, cough, and fatigue, significantly affecting quality of life and being a leading cause of death in these patients. The study focuses on whether adding belimumab to standard therapy can stabilize or improve lung function and relieve ILD symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both administered as a subcutaneous injection alongside their standard treatment. The study is a phase 3, double-blind, placebo-controlled trial designed to compare these two groups over time. Belimumab treatment is given under careful monitoring to assess its impact on lung disease progression. Throughout the study, participants will undergo assessments including lung function tests, specifically measuring forced vital capacity (FVC) at the start and after 52 weeks. Researchers will monitor changes in lung capacity to determine treatment effects. Participants will be evaluated for safety and symptom changes, with ongoing review of their ability to manage their condition. The total duration includes regular follow-ups and assessments to understand the long-term impact of the treatment.

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease (SSc-ILD). This Phase 2/3 randomized, double-blind study aims to assess how belimumab affects lung function and other disease symptoms such as skin thickening and fatigue, which impact quality of life. Participants will receive either belimumab or placebo administered subcutaneously. The study focuses on those diagnosed with diffuse cutaneous systemic sclerosis and active or progressive disease. Treatment is given under blinded conditions, and participants must be capable of self-administering the medication or have a caregiver to assist. During the study, lung function will be monitored by measuring changes in forced vital capacity (FVC) from baseline to Week 52. Researchers will also assess skin involvement and general symptoms. Safety and tolerability will be closely followed throughout the trial, which includes screening and regular assessments to evaluate treatment effects and participant well-being.

This research aims to evaluate the safety and effectiveness of TAK-279 in people with moderately to severely active Crohn's disease, a long-term condition that causes inflammation anywhere in the gut. The study seeks to determine if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. Participants will be assessed using endoscopy to check the level of bowel inflammation. Participants will be randomly assigned to one of four groups: three different doses of TAK-279 or a placebo. They will receive the assigned treatment capsules for a total of 52 weeks (1 year). The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given unless needed for urgent medical reasons. The trial will be conducted at multiple centers worldwide and involves 15 clinic visits. Throughout the study, participants will undergo assessments including endoscopy to measure treatment response based on the Simple Endoscopic Score for Crohn's Disease at week 12. Safety will also be monitored over approximately 60 weeks, including a 4-week safety follow-up period after treatment ends. Researchers will compare the medical problems experienced and how well participants tolerate the treatments.

Non-squamous non-small cell lung cancer (NSCLC) is a condition where abnormal lung cells grow uncontrollably. This research evaluates the safety and effects of telisotuzumab adizutecan combined with osimertinib, compared to standard care which includes osimertinib plus chemotherapy, as a first treatment for adults with advanced or metastatic EGFR-mutated NSCLC. The study is a Phase 2/3 trial conducted worldwide at about 200 sites, enrolling approximately 854 participants. The study has two stages. In Stage 1, participants receive increasing intravenous doses of telisotuzumab adizutecan along with oral osimertinib tablets, or standard care with osimertinib plus chemotherapy (cisplatin or carboplatin plus pemetrexed). Participants are then randomized into four groups to continue one of three telisotuzumab adizutecan doses with osimertinib or the standard care. In Stage 2, participants receive the optimal dose of telisotuzumab adizutecan with osimertinib or the standard care. Treatment and assessments may continue for up to approximately 76 months. Participants attend regular visits at approved hospitals or clinics for medical evaluations, blood tests, questionnaires, and side effect monitoring throughout the study. Researchers assess treatment response, progression-free survival, and adverse events. Tumor response is measured by blinded independent review using standardized criteria. The study aims to closely monitor safety and disease changes during the treatment period lasting up to about 6 years and 4 months.

Metastatic colorectal cancer (mCRC) is one of the most common cancers worldwide, especially in developed countries. This research aims to evaluate the safety and effectiveness of an investigational drug called telisotuzumab adizutecan given alongside standard chemotherapy drugs oxaliplatin, fluorouracil (5FU), leucovorin (LV), and either bevacizumab or panitumumab. The study is a phase 2 trial designed to assess side effects and changes in disease activity with these combinations. The study includes two stages. The first stage involves increasing doses of telisotuzumab adizutecan combined with FOLFOX (oxaliplatin, 5FU, leucovorin) and bevacizumab or 5FU/LV and panitumumab until a tolerable and effective dose is found. In the second stage, about 390 adult participants will be randomly assigned to receive one of two optimized doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator treatment of FOLFOX with bevacizumab or panitumumab. Treatments are delivered by intravenous infusion. Participants will have regular visits at hospitals or clinics over approximately six years. Researchers will monitor treatment effects through medical assessments, blood tests, questionnaires, and tracking side effects. The main outcomes include measuring tumor response based on standardized criteria (RECIST 1.1) up to 24 weeks and monitoring adverse events for up to six years to evaluate safety and disease control.