Bury

Researchers are evaluating the use of epigenome-guided treatment selection compared to the usual standard-of-care (SOC) treatment in adults with active Crohn's Disease (CD) who are starting biologic therapy. This multicenter, prospective, randomized, controlled, open-label study aims to assess the efficacy, safety, and cost-effectiveness of this approach by comparing clinical remission and endoscopic response at Week 26. About 378 participants with active CD, defined by specific clinical and endoscopic criteria, will be included, with roughly half being biologic-naive and the other half exposed to no more than one prior biologic treatment. Participants will be randomly assigned to either receive biologic therapy guided by an epigenetic biomarker assay and the EpiPredict software, which predicts response to two biologics (Vedolizumab or Ustekinumab) or to receive treatment selected according to usual SOC without epigenome guidance. Biologic therapies will be administered following product labels and local SOC recommendations, with dose adjustments allowed as needed. Study assessments will follow the SOC schedule for each biologic during the 26-week treatment period, with different visit weeks depending on the biologic used. Participants will undergo blood sample collection for epigenetic testing during screening. Study visits will include clinical and endoscopic assessments at specified weeks, with long-term follow-up every six months up to 24 months after Week 26 using medical records and questionnaires. Researchers will measure outcomes related to clinical remission and endoscopic response, safety, and cost-effectiveness. Participants' adherence and ability to comply with protocol requirements will be monitored throughout the study.

Researchers are evaluating the effects of tirzepatide compared with standard care in adults living with obesity who do not have diabetes. This phase 4 study aims to assess weight loss and the occurrence of type 2 diabetes over a long period in a real-world setting. Participants must have obesity and at least one weight-related health condition to join the study. Participants will receive either tirzepatide, given once weekly by injection under the skin, or continue with standard care as determined by their healthcare providers. The study is designed to reflect real-life treatment and monitoring situations to understand how tirzepatide works outside of tightly controlled clinical trials. The study lasts about 260 weeks, during which participants will be regularly monitored for changes in body weight and the development of type 2 diabetes. Measurements will be taken at the start and throughout the study to track weight changes. Researchers will also observe safety and overall health during this extended follow-up period.

Researchers are evaluating the efficacy and safety of induction therapy with Afimkibart (also called RO7790121) in people aged 16 to 80 years who have moderately to severely active Crohn's disease. This Phase III, multicenter, double-blind, placebo-controlled study focuses on how well Afimkibart works compared to placebo in improving symptoms and healing the intestine. Participants will receive Afimkibart either as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study includes a placebo group receiving a matching IV infusion. Treatment is given during the induction phase to assess the initial response. During the study, participants will be monitored for clinical remission using the Crohn's Disease Activity Index and for endoscopic response at 12 weeks. Researchers will assess safety, effectiveness, and any side effects throughout the study. Participants will undergo evaluations including symptom tracking and medical tests to measure treatment outcomes.

Researchers are evaluating the effects of different doses of SAR442970 compared to placebo in adults with moderate to severe Crohn's disease. This phase 2b, randomized, double-blind study aims to assess the safety and effectiveness of SAR442970 in treating this condition. Participants must have had Crohn's disease for at least three months and have shown inadequate response or intolerance to previous standard or advanced therapies. Participants will receive either SAR442970 or placebo through subcutaneous injections during the treatment period, which lasts up to 158 weeks. Eligible participants may continue into an open-label long-term extension phase for up to 104 weeks. The study includes three treatment groups to compare different doses of SAR442970 with placebo. Throughout the study, participants will be closely monitored with various assessments to measure their response to treatment, including the percentage achieving endoscopic response by Week 16. Researchers will also monitor safety and collect data over a total duration of up to 168 weeks. Participants will have regular visits for evaluations, including clinical assessments and adherence to treatment protocols.

This research aims to evaluate the effectiveness of different doses of SAR442970 compared to placebo in adults with moderate to severe Ulcerative Colitis. It is a phase 2b, randomized, double-blind study conducted across multiple centers and countries. The study includes participants who have had active Ulcerative Colitis for at least three months and meet specific disease activity criteria measured by the modified Mayo Score. Participants will receive either SAR442970 or placebo through subcutaneous injections. The treatment period can last up to 158 weeks and includes a long-term open-label extension lasting up to 104 weeks for those who qualify. This design allows for assessment of both short-term and longer-term effects of the study drug. Throughout the study, researchers will monitor participants regularly to assess clinical remission using the modified Mayo Score at Week 16 as the primary outcome. Participants will undergo clinical evaluations, endoscopy, and other assessments to track disease activity and safety. The total study duration can extend up to 168 weeks, ensuring thorough long-term observation and safety monitoring.

Researchers are investigating sovateltide, a new drug that targets ETB receptors, for treating acute cerebral ischemic stroke (ACIS), a condition caused by a blocked blood vessel in the brain leading to brain tissue damage. ACIS is the most common type of stroke and a serious emergency with limited treatment options. Current standard treatment with tissue plasminogen activator (t-PA) has a narrow time window and limited success in fully resolving stroke effects. Sovateltide has shown promise in animal studies and early human trials by promoting brain repair and improving neurological outcomes. The study compares sovateltide treatment alongside standard care to a placebo (normal saline) in patients who recently experienced ACIS. Participants will receive the study drug within 24 hours of stroke symptom onset. This phase III trial is randomized, double-blind, and placebo-controlled, conducted across multiple centers in the United States, Canada, the United Kingdom, and Europe. The trial builds on positive results from earlier phase II and III studies conducted in India. Participants will be followed for 90 days after treatment to assess recovery using scales that measure disability and neurological function. Researchers will monitor safety and effectiveness by evaluating participants' abilities and stroke outcomes, including the modified Rankin Scale score. The trial aims to provide further evidence on whether sovateltide can improve recovery and function after acute ischemic stroke when added to standard treatment.

Researchers are evaluating two different early treatment methods for adults hospitalized with sepsis, a serious condition caused by the body's extreme response to infection. This study focuses on comparing starting a vasopressor medication called norepinephrine immediately versus the standard approach of first giving fluid through a drip and then adding vasopressors if needed. The goal is to see which method better improves recovery, reduces complications, shortens hospital stay, and enhances long-term health. This is a Phase 3 clinical trial addressing a critical and complex condition with significant risks to patients' organs and survival. The study compares early peripheral vasopressor infusion (PVI) started within 12 hours of hospital admission targeting a mean arterial pressure (MAP) of 65 mmHg or higher, against the usual care involving intravenous fluids followed by vasopressors as needed. Norepinephrine is prepared at a concentration of 16 micrograms/ml and administered either as an early continuous infusion or after fluid resuscitation. Balanced crystalloid fluids are given according to standard care practices. Current guidelines and clinical practices inform the treatment approach, but this study aims to clarify the benefits of early vasopressor use in septic shock. Participants will be monitored for clinical effectiveness during the first 48 hours, with follow-up extending to 90 days after randomization. The study includes assessments such as blood pressure, serum lactate levels, and clinical status evaluations. Researchers will track recovery times, complications, hospital length of stay, and long-term health outcomes. Safety monitoring and evaluation of adverse effects will be ongoing throughout the study period to ensure participant well-being.

Researchers are evaluating the prevention of venous thromboembolism (VTE), which can be a serious complication after an acute stroke. This study is focused on immobile stroke patients who cannot walk without help and aims to compare two methods to prevent VTE during a 90-day follow-up period. The study compares the current standard treatment, Intermittent Pneumatic Compression (IPC), with a medical device called the geko17; device, which uses neuromuscular electrical stimulation to improve blood flow and potentially reduce VTE risk. Participants will be randomly assigned to receive either the IPC treatment, which involves air-filled cuffs squeezing the lower legs, or the geko17; device stimulating the peroneal nerve. Both treatments will be applied until the patient can walk independently or for up to 30 days. Leg compression Doppler scans will be done at 7 days (optional) and 14 days (mandatory) after randomisation. At 14 days, patients will also complete a questionnaire about device comfort and provide health information. Additional data on symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) will be collected from medical records at 30 days. During the study, participants will be monitored through scans, questionnaires, and medical record reviews to track any occurrences of DVT or PE. A final follow-up call at 90 days will assess the patient's recovery, health status, mobility, and quality of life. The main outcome measured is the frequency of symptomatic or asymptomatic DVT in the leg veins or any PE from randomisation up to 30 days. This comprehensive monitoring aims to provide clear information about which prevention method may better support immobile stroke patients.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are evaluating the safety and effectiveness of tilpisertib fosmecarbil (formerly GS-5290) in adults with moderate to severe ulcerative colitis. This Phase 2, double-blinded, randomized, placebo-controlled study aims to compare different doses of tilpisertib fosmecarbil with a placebo to see if it can achieve a clinical response by Week 12. Participants have ulcerative colitis confirmed by endoscopy and histology, with symptoms measured by a modified Mayo Clinic Score. Participants will receive oral tablets of either tilpisertib fosmecarbil or placebo during the study. The study includes multiple treatment groups with varying doses of tilpisertib fosmecarbil alongside a placebo group. The goal is to assess the dose-ranging efficacy and safety of this investigational drug in achieving clinical response in this patient population. During the 12-week treatment period, researchers will monitor participants for clinical response using the modified Mayo Clinic Score, which evaluates stool frequency, rectal bleeding, and endoscopic findings. Safety will also be assessed throughout the study. Participants must meet specific criteria including disease activity level, prior treatment history, and undergo necessary colonoscopy surveillance before randomization. The study enrolls adults aged 18 to 75 years and includes careful monitoring for infections and other medical conditions that might affect eligibility or safety.