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 oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.

Researchers are evaluating icotrokinra for its effectiveness and safety in people with moderately to severely active Crohns disease, a condition causing severe inflammation in the intestines. This clinical trial is a Phase 2b3 study aiming to understand how well icotrokinra works compared to placebo to improve symptoms and intestinal healing. Participants will be randomly assigned to receive one of several treatments two different doses of icotrokinra or a matching placebo, taken orally every day during an induction period of up to 12 weeks. Based on their response at Week 12, participants may continue with maintenance dosing or placebo up to Week 40. Those completing the maintenance phase may join a long-term extension study for further evaluation. During the trial, participants will be monitored with clinical assessments, endoscopy, and patient-reported outcomes to measure response, remission, and safety. The main outcomes include clinical response and remission at Weeks 12 and 40, along with endoscopic healing. Safety will be tracked through adverse event reporting up to four weeks after the last dose. The study is expected to continue until 2032, with multiple visits for treatment and evaluations throughout.

Researchers are evaluating tirzepatide in adults with obesity who do not have diabetes but have at least one weight-related health condition. The study aims to assess body weight loss and the development of type 2 diabetes over a long period in a real-world setting. This is a Phase 4 clinical trial sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either weekly subcutaneous injections of tirzepatide in addition to standard care or standard care alone. The study uses a parallel design to compare these two groups and lasts about 260 weeks 5 years. The focus is on long-term effects and real-world treatment outcomes. During the study, participants will have regular assessments including measurements of body weight, blood sugar control HbA1c, waist circumference, blood pressure, cholesterol, kidney function, quality of life, and healthcare resource use. The primary outcome is the percent change in body weight from baseline to 24 months. Secondary outcomes cover diabetes onset, metabolic changes, obesity-related complications, and quality of life over 60 months. Participants will be monitored throughout the study duration for safety and health changes.

Researchers are evaluating the efficacy and safety of Afimkibart also known as RO7790121 as an induction therapy in people aged 16 to 80 with moderately to severely active Crohns disease. This Phase III, multicenter, double-blind, placebo-controlled study aims to compare Afimkibart with placebo to understand its potential benefits and risks for this condition. Participants will be randomly assigned to receive either Afimkibart through an intravenous infusion followed by a subcutaneous injection, or a placebo infusion followed by Afimkibart subcutaneous injection. The study treatment is given to assess the impact on Crohns disease activity over a 12-week period. During the study, participants will have their symptoms and disease activity monitored using assessments like the Crohns Disease Activity Index CDAI, endoscopic evaluations, stool and abdominal pain tracking, and quality of life questionnaires. Safety will be closely observed up to 30 weeks after starting treatment. This study helps to measure remission rates and responses to treatment over time.

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 as a new treatment for acute cerebral ischemic stroke, a condition caused by a blockage in blood flow to the brain leading to tissue damage. This trial follows promising results from earlier studies in animals and humans showing sovateltides potential to improve neurological outcomes. The goal is to evaluate the safety and effectiveness of sovateltide combined with standard care for stroke patients in the United States and other countries. Participants will receive either sovateltide or normal saline as a placebo, both given as intravenous bolus doses within 24 hours of stroke onset. Three doses are administered on day 1, then repeated on days 3 and 6. The study is randomized, double-blind, and placebo-controlled, ensuring unbiased comparison between the treatment and control groups. During the study, patients will be monitored for neurological function and recovery using scales like the modified Rankin Scale, NIH Stroke Scale, and Barthel Index up to 90 days after treatment. Additional assessments include quality of life questionnaires, cognitive tests, and imaging to detect any complications. Safety is closely tracked throughout the study, which lasts about three months from treatment to final evaluation.

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.