Woodville

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating novel combination treatment options for adults 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 focused on specific NSCLC populations based on genomic alterations and PD-L1 expression levels. The study aims to assess the safety, tolerability, and preliminary antitumor activity of various drug combinations across approximately 80 centers worldwide. Participants will receive one of three investigational drug combinations administered by intravenous infusion rilvegostomig with or without ramucirumab for first-line NSCLC with non-actionable genomic alterations and varying PD-L1 expression levels, or Dato-DXd combined with ramucirumab with or without rilvegostomig for later-line NSCLC with actionable genomic alterations. Treatments continue until disease progression, unacceptable side effects, or withdrawal from the study. Each sub-study may include initial safety run-in cohorts followed by dose expansion cohorts. Throughout the study, participants will undergo regular evaluations including tumor imaging to assess response, clinical safety monitoring, and laboratory testing. Researchers will measure outcomes such as adverse events, objective response rates, progression-free survival, and overall survival over an average of three years. Pharmacokinetics and immunogenicity of the study drugs will also be monitored. Participation involves ongoing treatment and follow-up visits until study completion or discontinuation.

Researchers are evaluating the use of belimumab, in addition to standard therapy, for adults with interstitial lung disease ILD linked to connective tissue diseases CTDs such as rheumatoid arthritis and systemic lupus erythematosus. ILD causes lung inflammation and stiffness, leading to symptoms like shortness of breath and fatigue, and is a leading cause of death in people with these conditions. The study aims to see if belimumab can stabilize or improve lung function and symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both alongside their usual standard therapy. Belimumab is administered subcutaneously, and the study is designed as a phase 3, double-blind, placebo-controlled trial. The treatment period lasts 52 weeks, during which lung function and symptoms will be closely monitored. Participants will have assessments including lung function tests measuring forced vital capacity, symptom questionnaires, and imaging scans at the start and after 52 weeks. Researchers will also track safety by monitoring adverse events and hospitalizations related to respiratory issues. The overall study duration includes these evaluations up to 52 weeks to understand the treatments impact on lung disease progression and patient well-being.

Researchers are evaluating the efficacy and safety of belimumab compared to a placebo, both given alongside standard therapy, for adults with systemic sclerosis associated interstitial lung disease SSc-ILD. The study aims to assess how belimumab affects lung function, skin thickening, and symptoms like fatigue that influence quality of life in these patients. This is a Phase 23 randomized, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be randomly assigned to receive either belimumab or a placebo, both administered subcutaneously along with standard therapy. The treatment period lasts 52 weeks, during which the effects on lung function and skin symptoms will be closely monitored. The study involves two groups one receiving belimumab plus standard care and the other receiving placebo plus standard care. During the study, participants will undergo assessments including lung function tests such as Forced Vital Capacity FVC, skin thickness scoring, fatigue evaluations, and quality of life questionnaires at baseline and Week 52. Researchers will also track any adverse events and serious side effects. The main outcome measured is the change in lung function after 52 weeks. Participants will be monitored regularly throughout the 52-week treatment period to evaluate treatment effects and safety.

Researchers are evaluating the safety and effectiveness of TAK-279 in treating adults with moderately to severely active Crohns disease, a long-lasting condition causing inflammation in any part of the gut. This Phase 2b study aims to see if three different doses of TAK-279 can reduce bowel inflammation and ulcers compared to a placebo after 12 weeks of treatment. The study also compares medical problems experienced by participants taking TAK-279 or placebo and how well they tolerate these issues. An endoscopy will be used to assess bowel inflammation. Participants will be randomly assigned to one of four groups three groups receiving different doses of TAK-279 capsules and one group receiving placebo capsules. The treatment period lasts 52 weeks one year, followed by a 4-week safety follow-up. TAK-279 and placebo capsules are taken orally, and the study is conducted at multiple global centers. Treatment groups remain undisclosed to participants and doctors unless urgent medical needs arise. During the study, participants will visit the clinic 15 times for assessments, including endoscopies to check for bowel inflammation. Researchers will measure responses such as endoscopic improvement based on the Simple Endoscopic Score for Crohns Disease at week 12 and other clinical remission and response indicators. Quality of life and fatigue levels will also be evaluated. The total study duration is about 60 weeks, including treatment and follow-up.

Researchers are studying non-squamous non-small cell lung cancer NSCLC with specific mutations in the EGFR gene that cause abnormal cell growth in the lungs. This study aims to evaluate side effects and changes in disease activity when the investigational drug telisotuzumab adizutecan is combined with the approved drug osimertinib Osi, compared to standard care that includes Osi with chemotherapy. The study is conducted in two stages and includes adults with locally advanced or metastatic NSCLC. In the first stage, participants receive increasing intravenous doses of telisotuzumab adizutecan along with oral osimertinib. Then, participants are randomly assigned to one of several groups receiving different doses of telisotuzumab adizutecan plus Osi or the standard of care involving Osi plus chemotherapy. In the second stage, participants receive the optimal dose of telisotuzumab adizutecan with Osi or standard care. The study treatments will be given over approximately 76 months at medical centers worldwide. Participants will attend regular visits where doctors will monitor treatment effects through medical exams, blood tests, questionnaires, and side effect evaluations. Researchers will measure tumor response, progression-free survival, and adverse events over the study period. Quality of life and lung cancer symptoms will also be assessed using questionnaires. Safety and disease activity will be closely followed throughout the long duration of the trial.

Researchers are evaluating the effects of Dato-DXd combined with osimertinib or Dato-DXd alone compared to platinum-based doublet chemotherapy in people with EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC whose disease progressed after prior osimertinib treatment. This Phase III, open-label, randomized study aims to compare progression-free survival among these treatments to better understand options for this condition. Participants are randomly assigned to one of three groups Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd is given as an intravenous infusion every 3 weeks, osimertinib is taken orally daily, and chemotherapy involves pemetrexed combined with carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance pemetrexed. Treatments continue until disease progression, unacceptable side effects, or other reasons to stop. Throughout the study, participants undergo regular assessments including radiological scans to monitor tumor response using RECIST v1.1 criteria, safety evaluations, and health status measurements. After stopping treatment, an end-of-treatment visit occurs within 35 days, followed by safety follow-up 28 days after the last dose. The study primarily measures progression-free survival over up to 2.5 years, with additional outcomes including overall survival, response rates, quality of life, and pharmacokinetics monitored for up to 3.5 years.

Researchers are evaluating a new combination of medicines, DSP107 and atezolizumab, compared with an existing treatment, fruquintinib, for patients with advanced microsatellite stable colorectal cancer. This Phase 2b, randomized, open-label study focuses on individuals whose cancer has progressed or who cannot tolerate standard therapies. The study aims to assess whether the new combination improves treatment outcomes and safety compared to the current treatment options. Participants are randomly assigned to one of two groups. One group receives DSP107 intravenously on Days 1, 8, and 15 of each 28-day cycle with atezolizumab given intravenously on Day 1. The other group takes fruquintinib orally once daily on Days 1 to 21 of each 28-day cycle. The study includes a screening period of up to 28 days, a treatment period lasting up to 24 cycles, a safety follow-up period of up to 90 days after the last dose, and a long-term follow-up lasting up to 5 years from randomization. During the study, participants will have medical evaluations including monitoring of cancer response, safety assessments, and tests such as ECG and blood pressure measurements. Quality of life and immune response to treatment will also be tracked. Participants maintain dosing diaries if assigned to the oral treatment group. The primary outcome is overall survival, with ongoing safety and health status follow-up conducted for several years after treatment. Total study participation duration varies based on treatment tolerability and disease progression.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.