Bury

Researchers are evaluating the use of epigenome-guided treatment selection compared to the usual standard-of-care SOC treatment for adults with active Crohns Disease CD. This study aims to assess the effectiveness, safety, and cost-effectiveness of using an epigenetic biomarker assay and machine-learning software called EpiPredict to help choose between two biologic therapies, Vedolizumab VDZ and Ustekinumab UST, for treating active CD. The trial includes participants who have active disease and are either new to biologic therapy or have had limited prior biologic exposure. Participants will be randomly assigned to one of two groups one group will receive biologic treatment guided by the EpiPredict software based on epigenetic blood tests, which indicates the likelihood of response to VDZ or UST, while the other group will receive biologic therapy following usual SOC without epigenetic guidance. Both groups will receive their biologic therapy according to approved product labels, with dose adjustments allowed as needed by the treating doctor. Treatment and assessments will be carried out over 26 weeks, with different assessment schedules depending on the biologic received. After this treatment period, participants will have long-term follow-up every six months up to 24 months. During the study, participants will provide blood samples for epigenetic testing and undergo clinical and endoscopic evaluations to monitor their disease activity and response to treatment. Data will also be collected from routine medical records and online questionnaires during follow-up visits. The primary measurement is the comparison of clinical remission and endoscopic response rates at Week 26 between the two treatment selection methods. Researchers will also evaluate cost-effectiveness and explore how well the epigenetic assay predicts treatment success. Participants are required to comply with study procedures and provide informed consent to participate fully.

Researchers are evaluating the effectiveness, safety, and tolerability of oral icotrokinra in treating adults and adolescents with moderately to severely active ulcerative colitis UC, a chronic condition where the large intestine lining becomes inflamed and develops ulcers. This Phase 3 clinical trial aims to compare icotrokinra with a placebo to better understand its impact on UC symptoms and remission rates. Participants will be divided into study groups receiving either icotrokinra or a placebo orally each day starting from Week 0 of the induction phase. After 12 weeks, responses will be assessed and participants who respond to icotrokinra or placebo enter a maintenance phase lasting up to Week 40. Adolescents receive open-label icotrokinra throughout the study, with an option for a long-term extension after completing the maintenance phase. During the trial, participants will undergo regular evaluations including clinical response, endoscopic assessments, and symptom monitoring at key points such as Weeks 12 and 40. Researchers will track remission rates, symptom improvements, quality of life, and safety outcomes. The study involves both double-blind and open-label phases and continues until January 2032, with close monitoring to understand how participants respond over time.

Researchers are evaluating how well icotrokinra works and how safe it is for people with moderately to severely active Crohns disease, a condition that causes long-term inflammation in the intestines. This study is a Phase 2b3 trial that aims to understand both the effectiveness and safety of icotrokinra in treating this condition. Participants will receive icotrokinra or a matching placebo orally every day during the induction period lasting up to 12 weeks. Those who respond to the treatment at Week 12 may continue with different dosing options of icotrokinra or placebo during a maintenance phase up to Week 40. Following this, eligible participants can join a long-term extension study to further monitor treatment effects. During the study, participants will undergo evaluations of their clinical response, remission, and endoscopic response at Weeks 12 and 40 using established disease activity scores. Researchers will monitor safety by tracking adverse events up to 4 weeks after the last dose. The study includes regular assessments through endoscopy, patient-reported outcomes, and laboratory tests to measure how the disease and treatment effects progress.

Researchers are evaluating tirzepatide in adults with obesity but without diabetes to study its effects on weight loss and the development of type 2 diabetes in a real-world setting. This phase 4 study compares tirzepatide combined with standard care against standard care alone, focusing on body weight changes and diabetes incidence over several years. Participants will be randomly assigned to receive either weekly subcutaneous injections of tirzepatide plus standard care or standard care alone. The study will last about 260 weeks 5 years, with key measurements taken at baseline, 24 months, and up to 60 months. Outcomes include changes in body weight, onset of type 2 diabetes, glycemic control, waist measurements, cholesterol, blood pressure, kidney function, quality of life, and healthcare resource use. During the study, participants will undergo regular assessments of weight, blood tests including hemoglobin A1c, blood pressure, and other health indicators. Researchers will monitor diabetes development and obesity-related complications, as well as the impact on quality of life. Safety and effectiveness data will be collected throughout the long-term follow-up, helping to understand tirzepatides role in managing obesity without diabetes.

Researchers are evaluating the effectiveness and safety of induction therapy using Afimkibart RO7790121 in people with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled trial aims to understand how well this treatment works compared to placebo during the induction phase. The study focuses on participants who have not responded adequately to other conventional or advanced therapies for Crohns disease. Participants will be randomly assigned to receive either Afimkibart through an intravenous IV infusion followed by subcutaneous SC injections or a placebo IV infusion followed by Afimkibart SC injections. This treatment schedule is designed to assess the induction effectiveness of Afimkibart in reducing disease activity over a 12-week period. The study includes two treatment groups to compare outcomes between the active drug and placebo. During the study, participants will be monitored for clinical remission and endoscopic response at week 12, along with other measures such as symptomatic remission, bowel urgency, abdominal pain, stool consistency, fatigue, and quality of life questionnaires. Safety assessments will continue for up to 30 weeks after baseline to record any adverse events. Participants will attend scheduled visits for evaluations and laboratory tests to track progress and response to treatment throughout the trial.

Researchers are evaluating SAR442970, a drug given by injection under the skin, for adults with moderate to severe Crohns disease. This phase 2b, randomized, double-blind study compares two different doses of SAR442970 with placebo to understand its effects on the condition. The study aims to measure how many participants achieve an endoscopic response by Week 16, among other clinical improvements. Participants are randomly assigned to receive one of three treatments SAR442970 dose regimen A, SAR442970 dose regimen B, or placebo. Treatments are given subcutaneously, and the study includes a treatment period lasting up to 158 weeks. There is also an open-label long-term extension phase lasting up to 104 weeks for those who qualify, allowing continued evaluation of SAR442970s effects over time. During the study, participants will undergo assessments including endoscopic exams, clinical remission evaluations using the Crohns Disease Activity Index CDAI, patient-reported outcomes, and quality-of-life questionnaires. Safety is monitored by tracking adverse events and measuring drug levels in the blood. The total participation time can be up to 168 weeks, with ongoing evaluations to assess both short- and long-term outcomes.

Researchers are investigating the effectiveness and safety of SAR442970 in adults with moderate to severe Ulcerative Colitis in a phase 2b randomized, double-blind study. The trial compares two different doses of SAR442970 against a placebo to see how well they work in treating this condition. The total study duration can last up to 168 weeks, including a long-term extension period for eligible participants. Participants will be randomly assigned to receive one of three treatments SAR442970 dose regimen A, SAR442970 dose regimen B, or a matching placebo, all given by subcutaneous injection. The study includes a treatment period lasting up to 158 weeks, followed by an open-label long-term extension phase of up to 104 weeks for those who qualify. Throughout the study, participants will undergo regular assessments to measure clinical remission using the modified Mayo Score at Week 16, as well as other outcomes such as endoscopic improvement, histological remission, and patient-reported outcomes. Safety will be monitored by tracking adverse events. Blood samples for drug concentration and antibodies will also be collected. The overall participation may last up to approximately 164 weeks.

Researchers are investigating sovateltide, a drug that targets ETB receptors, as a potential treatment for acute cerebral ischemic stroke, a serious condition caused by a blocked blood vessel in the brain. This type of stroke leads to brain tissue damage due to lack of oxygen and is more common than hemorrhagic stroke. Previous studies in animals and early human trials have shown sovateltide may help protect and repair brain cells, encouraging further research in a phase III clinical trial across multiple countries. The study compares sovateltide with a placebo normal saline alongside standard care for stroke patients. Participants receive three intravenous bolus doses of sovateltide or placebo over one minute each, spaced every 3 hours on day 1, with repeated dosing on days 3 and 6. The treatment starts within 24 hours after stroke symptoms begin. This randomized, double-blind trial aims to assess safety and how well sovateltide improves recovery compared to placebo. Participants will be closely monitored over 90 days, with evaluations including neurological function using scales like the modified Rankin Scale, National Institute of Health Stroke Scale, and Barthel Index. Quality of life and cognitive function will also be assessed at multiple points. Researchers will track any adverse events, recurrent strokes, and mortality. The study requires patients to be available for full treatment and follow-up to measure sovateltides effects comprehensively.

Sepsis is a serious condition caused by the bodys extreme response to an infection, leading to tissue and organ damage. This research compares two early treatment methods for sepsis immediately after hospital arrival, focusing on whether starting vasopressor medication right away or beginning with fluid therapy improves patient recovery and reduces complications. The study is a Phase 3 trial aimed at finding the best approach to improve outcomes for adults with septic shock. Participants are divided into two groups one receives a continuous peripheral vasopressor infusion of norepinephrine during the first 48 hours, while the other group receives standard care guided by UK NICE and Surviving Sepsis Campaign guidelines, which starts with intravenous fluids and adds vasopressors as needed. Both treatments follow local hospital protocols beyond the initial interventions. During the study, participants will be closely monitored for blood pressure, fluid volume, lactate levels, and other health indicators at multiple time points up to 90 days after randomization. Researchers will assess outcomes including hospital stay length, need for additional therapies like renal replacement or respiratory support, and overall survival. Quality of life and readmission rates will also be evaluated to understand the longer-term effects of the treatments.

Researchers are evaluating the prevention of venous thromboembolism VTE, a serious condition that can occur after a stroke, in immobile patients. This study compares the current standard treatment, Intermittent Pneumatic Compression IPC, with a medical device called the geko device, which uses neuromuscular electrostimulation to increase blood circulation. The study focuses on whether the geko device can better prevent VTE during a 90-day follow-up period after stroke. Participants will be randomly assigned to one of two groups one receiving the geko device and the other receiving standard IPC treatment. The geko devices will be applied to both legs and changed every 24 hours, used continuously for up to 30 days or until the patient regains mobility. The IPC devices will also be applied to both legs and used up to 30 days or until recovery or discharge. Treatment will start soon after randomization. During the study, participants will have leg Doppler ultrasound exams at 7 days optional and 14 days mandatory to check for blood clots. At 14 days, patients will complete a questionnaire about device comfort and health information. At 30 days, medical records will be reviewed for any symptomatic deep vein thrombosis or pulmonary embolism. A final phone follow-up at 90 days will assess recovery, health, mobility, quality of life, and survival. Safety and device effectiveness will also be monitored throughout the study period.