Lake Jackson

Researchers are investigating the efficacy and safety of duvakitug in people with moderately to severely active Crohns Disease in a multinational, multicenter, randomized, double-blind, placebo-controlled Phase 3 study. The trial includes three sub-studies aiming to evaluate duvakitugs effects compared to placebo during induction treatment phases, focusing on clinical remission and endoscopic response at 12 weeks. Participants receive subcutaneous injections of duvakitug or placebo following the study protocol. The study duration can be up to 35 weeks, including a screening period of up to 5 weeks, followed by a 12-week induction phase in either Sub-Study 1 open-label, Sub-Study 2 pivotal induction, or Sub-Study 3 extended induction for non-responders. A 6-week follow-up period applies to participants not entering the maintenance study. Throughout the trial, participants undergo scheduled visits for assessments including clinical remission based on Crohns Disease Activity Index and endoscopic scores. Safety is monitored with reports of adverse events and serum drug levels. Up to 8 to 15 visits are planned depending on the sub-study, with follow-up continuing for 45 days after the last dose for those not moving to maintenance treatment.

Researchers are evaluating the efficacy and safety of duvakitug, a drug given by subcutaneous injection, in people with moderately to severely active Ulcerative Colitis UC. This Phase 3 randomized, double-blind, placebo-controlled study includes participants aged 16 to 80 years and aims to assess clinical remission and other health improvements over a series of treatment periods. The study lasts up to 35 weeks and includes a screening period followed by three possible sub-studies a 12-week open-label induction, a 12-week pivotal induction, and a 12-week extended induction for those who do not respond initially. Participants receive injections of either duvakitug at one of two doses or placebo according to the study protocol, with up to 15 visits scheduled for those in extended induction. During the study, participants will undergo assessments including clinical remission rates at week 12, endoscopic and histological improvements, symptom tracking, quality of life questionnaires, and safety monitoring for adverse events. Follow-up visits occur up to 45 days after the last dose for those not continuing in the maintenance study. Researchers will also measure drug levels and immune responses over the study period to better understand treatment effects.

Researchers are evaluating the Dozee VS system, a contactless device designed to monitor heart rate and breathing rate in adults within clinical settings. The study aims to validate updated AI-powered heart rate and improved breathing rate algorithms across different types of sensor sheets to confirm their clinical accuracy compared to standard monitoring methods. The Dozee VS device uses a thin sensor sheet placed under the mattress to detect tiny body vibrations caused by the heart and lungs. These signals are processed by smart algorithms and shown on a secure online dashboard for real-time remote monitoring. The system supports add-on devices like a blood pressure cuff, pulse oximeter, and thermometer. This study evaluates the new generation of heart rate and respiratory rate algorithms with three sensor sheet types DS, S1, and S1-I to meet clinical standards. Participants will be monitored simultaneously with standard telemetry devices measuring heart and respiratory rates using electrocardiography and capnography while also using the Dozee VS system. Data is collected over six months to assess the mean absolute error of Dozees measurements against gold standard devices. The study includes assessments of vital signs without requiring patient compliance with wearables and offers continuous, non-invasive monitoring in clinical environments.

This research aims to evaluate the efficacy and safety of rimegepant compared to a placebo as a preventive treatment for migraine in children and adolescents aged 6 to under 18 years with episodic migraine. It focuses on reducing the frequency of migraine days over a 12-week period, particularly in young patients who experience mild to moderate disruption in daily activities due to migraine. The study is designed as a Phase 3 randomized, double-blind trial to assess this preventive approach. Participants will be randomly assigned to receive either rimegepant at doses of 75mg or 50mg two 25mg orally disintegrating tablets or a matching placebo with the same dosing options. The treatment phase lasts 12 weeks in a double-blind manner, followed by a safety and tolerability evaluation over a total of 72 weeks. The study includes sequential treatment with careful monitoring of migraine frequency and medication use during this period. Throughout the trial, participants will be monitored for migraine days per month, reduction in migraine frequency, and quality of life as measured by the Pediatric Quality of Life Inventory PedsQL. Researchers will also assess the use of acute migraine medications, hepatic-related adverse events, and overall safety. The primary outcome focuses on the change in migraine days during the 12-week treatment phase. Participants adherence and safety will be tracked throughout the treatment and follow-up periods, lasting up to nearly 10 years until study completion.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.