Brooksville

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating the potential of GB-0895, an investigational drug, as an additional treatment for adolescents and adults with severe asthma that is not well controlled by inhaled corticosteroids and other common asthma medications. This global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of GB-0895 over one year, with an optional extension phase. The study includes participants aged 12 to 80 years with documented severe uncontrolled asthma despite current therapy. Participants will be randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every six months during the 52-week treatment period. The study also includes phases for screening and run-in before treatment, followed by a follow-up period lasting up to 38 weeks after treatment ends. An optional open-label extension allows participants to continue receiving GB-0895 at specified weeks after the initial treatment phase. During the study, participants will attend visits every 1 to 2 months after the first month to monitor health and treatment effects. Assessments include lung function tests, asthma symptom questionnaires, quality of life evaluations, and tracking of asthma exacerbations. Researchers will closely monitor safety and treatment responses through these evaluations and collect data on various health measures to understand the drugs impact on severe asthma over the course of the study.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.

Asthma is a long-term condition where the airways become narrow and swollen due to inflammation, causing symptoms that can vary and worsen unexpectedly. This trial is evaluating depemokimab, a monoclonal antibody, to see how it impacts lung structure and function in adults with type 2 inflammatory asthma, particularly those with an eosinophilic phenotype. The study is a Phase 3b treatment trial sponsored by GlaxoSmithKline. Participants with asthma characterized by type 2 inflammation will receive depemokimab. The study uses advanced imaging and bronchoscopy to assess changes in lung features. Treatment involves administering depemokimab, with evaluations performed up to 52 weeks. Participants who consent to a biopsy sub-study will undergo additional bronchoscopy procedures under specific safety criteria. During the study, participants will undergo lung imaging, bronchoscopy, and tests measuring mucus plug volume, airway wall thickness, and lung function at several time points including weeks 26 and 52. Researchers will monitor side effects and serious adverse events up to 65 weeks. The total study duration allows detailed assessment of depemokimabs effects on lung health and participant safety.

Researchers are evaluating whether survodutide can help adults with liver diseases called non-alcoholic steatohepatitis NASH or metabolic-associated steatohepatitis MASH who have cirrhosis and a body mass index BMI of 27 kgm2 or higher 25 kgm2 for Asian participants. The study compares survodutide to a placebo to see if it improves liver function and related health outcomes over time. This is a Phase III trial with participants randomly assigned to groups, and it is double-blind, meaning neither participants nor doctors know who gets the medicine or placebo. Participants receive weekly injections of survodutide or placebo under the skin and get regular counseling on diet and exercise. The study lasts up to four and a half years, with visits either in person or via video call every 2, 4, or 6 weeks for about 17 months, then every 3 months thereafter until the study ends. The study collects health data including body weight, liver imaging results, and symptom questionnaires to assess the treatment effects. During the study, doctors monitor participants health and record any side effects. Liver health is checked using imaging methods at certain visits, and participants fill out questionnaires about their symptoms. The primary outcome measures include time to serious liver-related events and overall survival. Secondary outcomes look at changes in liver fibrosis, body weight, blood sugar control, liver stiffness, and other blood markers. The study aims to provide detailed long-term information on survodutides impact on liver disease and safety.

Researchers are evaluating survodutide, a medicine given by weekly injection, in adults aged 18 and older who have obesity and a liver disease called non-alcoholic steatohepatitis NASH or metabolic associated steatohepatitis MASH with moderate or advanced liver fibrosis. The study aims to see if survodutide can improve liver function and slow disease progression. This Phase III trial compares survodutide to a placebo, with participants randomly assigned to one of the two groups, and neither participants nor doctors know who receives which treatment. Participants inject survodutide or placebo under their skin once a week, with doses gradually increasing to a target level. All participants also receive counseling to encourage diet changes and regular exercise. The study has two parts the first focuses on the effect of survodutide on liver fibrosis and MASH over 52 weeks, and the second assesses long-term safety and effectiveness up to 7 years. Participants are involved for up to 7 years, with visits to the study site or remote video calls starting every 2 weeks, then every 4 and 6 weeks, and eventually alternating every 3 months. During visits, doctors monitor health, weight, and digestive effects, perform liver imaging, and collect liver tissue samples at select times. Participants complete questionnaires about symptoms and quality of life. Researchers measure changes in liver disease markers, body weight, blood tests, and monitor safety and serious outcomes like progression to cirrhosis or liver-related events.