Search Bar & Filters

Found 6 Actively Recruiting clinical trials

A

Actively Recruiting

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Age: 18Years - 80YearsAll GendersPhase 2
98 locations
A

Actively Recruiting

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Age: 18Years +All GendersPhase 3
1264 locations
A

Actively Recruiting

Researchers are evaluating the safety and effectiveness of subcutaneous anifrolumab compared with placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies (IIM), specifically polymyositis (PM) or dermatomyositis (DM). This multicenter, randomized, double-blind, placebo-controlled Phase III study adds anifrolumab or placebo to participants' standard of care treatment to assess overall disease activity. Participants will receive weekly subcutaneous injections of either anifrolumab or placebo for 52 weeks. After this period, all participants will receive open-label anifrolumab injections once weekly for an additional 52 weeks. This design allows researchers to evaluate initial treatment effects and longer-term outcomes with anifrolumab. During the study, participants will be monitored regularly for disease activity and safety. The main outcome measured is the Total Improvement Score (TIS) with a response defined as a score of 40 or higher at 52 weeks. The total study participation lasts up to 104 weeks, including the double-blind and open-label extension periods, ensuring comprehensive assessment of the treatment's impact and participant safety.

Age: 18Years - 75YearsAll GendersPhase 3
234 locations
E

Actively Recruiting

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with moderate to severe systemic primary Sjogren's disease. This Phase 2b study compares IMVT-1402 to a placebo using a double-blind, randomized, placebo-controlled design. The main goal is to see how the treatment affects disease activity scores over 24 weeks, with participation lasting up to 105 weeks. Participants receive either IMVT-1402 or placebo through weekly subcutaneous injections. The study carefully monitors changes in disease activity, focusing on a clinical score called clinESSDAI. The trial includes a long observation period to track both the treatment's effects and safety over time. During the study, participants undergo evaluations at the start and at week 24 to measure changes in their disease activity. Researchers will also monitor safety and tolerability throughout the entire study period. Participants are assessed for antibody status, salivary flow, and systemic disease activity to understand the impact of the treatment fully.

Age: 18Years - 74YearsAll GendersPhase 2
121 locations
R

Actively Recruiting

Healthy Volunteer

This research evaluates a new way to model the effects of propofol, a common anesthesia drug, in healthy patients undergoing planned surgery. It focuses on re-assessing the effect site model called Eleveld's PKPD model, which uses multiple patient factors and plasma levels to predict propofol's impact. The study aims to improve how the brain's electrical activity, measured by BIS index and spectral density of alpha and delta waves, reflects the drug's effects during anesthesia. Participants will receive a very slow induction of propofol until they lose consciousness, followed by remifentanil and rocuronium administration for intubation. Five minutes after intubation, propofol is infused at 15 mg/kg/h until a 1% burst suppression ratio is reached on the BIS monitor, then the infusion is reduced to the predicted concentration causing loss of consciousness. This process allows comparison between the predicted BIS index from the model and the actual BIS index observed, alongside evaluation of brain wave changes over time. Throughout the study, patients' brain activity is monitored using BIS and spectrogram analysis to measure alpha and delta power changes. The main outcome is to compare predicted and real BIS index values. Safety and response are closely observed during surgery and anesthesia. Total participation covers the surgical procedure and anesthesia period, focusing on brain electrical activity and drug effect modeling.

Age: 18Years - 65YearsAll GendersPhase 4
1 location
X

Actively Recruiting

Healthy Volunteer

Researchers are comparing 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. This randomized controlled trial includes three groups with 13 participants in XKS, 14 in NSS, and 16 in the control group. The study focuses on changes in percent body fat, fat-free mass, hand grip strength, chair stand test, timed up-and-go test, sit-and-reach test, and step test over 12 weeks. Participants will engage in physical activity using sports games that increase in complexity and intensity as levels advance, requiring faster and more demanding movements. The intervention aims to assess how these gaming activities impact body composition and physical performance measures compared to inactivity. During the study, older women will be assessed at the start and after 12 weeks on various physical tests and body composition measures. Researchers will monitor attendance to ensure at least 85% participation in sessions. The main outcomes include changes in fat-free mass, body fat percentage, hand grip strength, chair stand test, timed up-and-go test, sit-and-reach test, and step test performance to evaluate physical improvements.

Age: 60Years - 75YearsFEMALEPhase Not Applicable
1 location