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Found 9 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Age: 18Years - 80YearsAll GendersPhase 2
104 locations
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Actively Recruiting

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Age: 18Years +All GendersPhase 3
321 locations
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Actively Recruiting

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Age: 18Years +All GendersPhase 3
1365 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Age: 18Years - 75YearsAll GendersPhase 2
259 locations
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Actively Recruiting

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Age: 18Years - 75YearsAll GendersPhase 3
236 locations
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Actively Recruiting

This clinical trial investigates the best way to use prone position placing patients on their stomachs for adults with moderate to severe Acute Respiratory Distress Syndrome ARDS who need mechanical ventilation. Researchers want to find out if longer prone sessions lasting more than 48 hours improve survival compared to daily sessions lasting 16 to 24 hours. The study also evaluates the safety of prolonged prone positioning and its impact on medical problems related to this intervention. Participants are randomly assigned to one of two groups one receiving prolonged prone position sessions lasting at least 48 hours and up to 120 hours until their oxygenation improves, and the other receiving intermittent daily prone sessions lasting between 16 and 24 hours. Both groups may have repeated prone sessions during the first 7 days if their oxygen levels fall below a certain threshold after returning to the supine position. This design allows comparison of continuous versus intermittent prone positioning in managing ARDS. During the study, participants will be followed for up to 90 days to monitor their clinical progress. Researchers will assess outcomes including mortality at 28 and 90 days, ventilator-free days, and hospital-free days at 28 days. Safety and adverse events related to prone positioning will also be recorded. The total participation involves receiving the assigned prone sessions during the first week and ongoing clinical follow-up to evaluate the effectiveness and safety of each approach.

Age: 18Years +All GendersPhase Not Applicable
38 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of IMVT-1402 in adults with moderate to severe primary Sjogrens disease, a condition characterized by systemic symptoms. This Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study aims to compare IMVT-1402 to a placebo by measuring changes in disease activity at 24 weeks. Participants will receive weekly subcutaneous injections of either IMVT-1402 at one of two doses or a placebo. The study includes a treatment phase with dosing and monitoring, followed by ongoing participation lasting up to 105 weeks total for each individual. Throughout the study, participants will undergo regular assessments including clinical disease activity scoring using the Clinical European League Against Rheumatism Sjogrens Syndrome Disease Activity Index clinESSDAI. Additional evaluations include physician assessments of disease activity and antibody testing. Safety and tolerability will be closely monitored during the entire study duration.

Age: 18Years - 74YearsAll GendersPhase 2
121 locations
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Actively Recruiting

Healthy Volunteer

This research aims to compare the effects of Xbox Kinect Sports XKS and Nintendo Switch Sports NSS against an inactive control group on body composition and physical performance in physically inactive older women aged 60 to 75. The study is a randomized controlled trial with three parallel groups, focusing on outcomes like body fat percentage, fat-free mass, hand grip strength, chair stand test, timed get up and walk test, sit and reach test, and a 2-minute step test. Participants will be randomly assigned to one of three groups Xbox Kinect Sports, Nintendo Switch Sports, or a control group. Both intervention groups will engage in 12 weeks of training consisting of 36 sessions, each session including a 10-minute warm-up, 40 minutes of active exergames such as volleyball, bowling, boxing, fencing, and tennis, and a 10-minute cool-down with flexibility exercises. The control group will participate in initial and final assessments and play board games twice a week for 60 minutes. Throughout the study, participants will undergo assessments of physical performance and body composition at the beginning and end of the 12 weeks. Researchers will monitor adherence to sessions, and the primary outcomes will be measured two weeks after the intervention ends. The study will also collect demographic data such as age, academic level, and civil status. Safety and ethical standards are maintained, with informed consent and approval by a scientific ethics committee.

Age: 60Years - 75YearsFEMALEPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.

Age: 18Years +All GendersPhase 3
995 locations