Jiujiang

Researchers are evaluating the safety, tolerability, and effectiveness of SCTB35 in patients diagnosed with systemic lupus erythematosus (SLE). This multicenter clinical trial includes Phase Ib and II stages, aiming to find the highest safe dose and recommended dose for further study. The trial also compares how well SCTB35 works and how safe it is at these doses. The study has two parts: dose-escalation and dose-expansion. In the dose-escalation phase, participants receive increasing doses of SCTB35 by subcutaneous injection to find the maximum tolerated dose and recommended Phase II dose, guided by a Safety Review Committee. After confirming the recommended dose, the dose-expansion phase begins, applying this dose to more participants to further assess safety and preliminary effectiveness. Participants will be monitored from the first dose up to 24 weeks for side effects and response to treatment. The study measures include the rate of adverse events during the dose-escalation phase and improvement in disease activity scores during the dose-expansion phase. Researchers will also conduct safety reviews, monitor drug effects, and assess treatment benefits throughout the study period.

Researchers are evaluating the immune response and safety of a single dose of the RSVPreF3 OA investigational vaccine in Chinese adults aged 18 to 59 years who are at increased risk of respiratory syncytial virus (RSV) disease. This Phase 3, randomized, controlled, observer-blind study compares immune responses in this group to those of older adults aged 60 years and above from a previous study. The goal is to understand how well the vaccine stimulates immunity and assess its safety and side effects in this younger adult population at risk. Participants will receive one dose of either the RSVPreF3 OA vaccine or a placebo, both administered as an injection into the deltoid muscle of the non-dominant arm. The study focuses on observing the immune response one month after vaccination by measuring RSV-A and RSV-B neutralizing antibody levels. The vaccine and placebo administration and follow-up procedures are carefully controlled and monitored. During the study, participants will be closely monitored for immune responses through blood tests measuring neutralizing antibodies against RSV types A and B 31 days after vaccination. Safety and reactogenicity will also be assessed throughout the trial. The total duration involves vaccination and follow-up visits to ensure comprehensive evaluation of the vaccine's effects and participant safety.

Researchers are evaluating the safety and effectiveness of 9MW1911 in people with Chronic Obstructive Pulmonary Disease (COPD) through a Phase II, multicenter, double-blind, randomized, placebo-controlled clinical trial. The study focuses on patients aged 40 to 75 years who have a history of moderate to severe COPD exacerbations and moderate-to-severe COPD lung function impairment. This trial aims to compare 9MW1911 to a placebo to better understand its impact on COPD symptoms and exacerbations. Participants will be assigned to receive either intravenous 9MW1911 or a placebo every 28 days. The treatment period lasts 52 weeks, during which the study drug is administered monthly. The trial includes careful monitoring and evaluation of the participants' lung function and health status throughout this time to assess the effects of the treatment. During the study, participants will undergo various assessments including lung function tests and monitoring for COPD flare-ups or exacerbations. The primary outcome measured is the annual rate of moderate to severe acute COPD exacerbations over 52 weeks. Safety evaluations and regular health checks will also be conducted to ensure participant well-being. The total duration of participation in the trial is one year, providing comprehensive data on treatment effects and safety.

Researchers are evaluating the ability of dapirolizumab pegol (DZP) added to standard care medications to improve moderate to severe systemic lupus erythematosus (SLE) symptoms over the long term. This Phase 3 trial focuses on participants aged 16 and older who have active SLE with specific disease activity and serological markers. The goal is to assess clinical improvement using the British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) at Week 48. Participants will be randomly assigned to receive either dapirolizumab pegol (DZP) or placebo at scheduled times alongside their stable standard of care treatments. Standard medications include antimalarials combined with glucocorticoids and/or immunosuppressants or glucocorticoids and/or immunosuppressants alone if antimalarials are not suitable. The study is double-blind and placebo-controlled, ensuring unbiased comparison between the two groups. Throughout the study, participants will undergo regular assessments to monitor disease activity and treatment safety up to Week 48. Researchers will track responses based on disease activity indices and monitor for any adverse effects. The study includes careful screening and follow-up evaluations to understand the long-term effects of adding DZP to usual care in people with moderately to severely active SLE.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the effectiveness and safety of Sodium Oligomannate (GV-971) in treating mild to moderate Alzheimer's disease. This Phase 4, multi-center, randomized, double-blind, placebo-controlled study aims to confirm how GV-971 works in the body, identify known side effects from long-term use, and watch for any new adverse reactions to guide clinical use. Participants in the study will receive either GV-971 or a placebo, both taken orally, over a period of 36 weeks. The study measures changes from the beginning in cognitive function using the ADAS-cog/12 score and daily living activities using the ADCS-ADL23 score. During the trial, participants will undergo brain MRI scans to confirm Alzheimer's diagnosis and will be monitored through various assessments including cognitive and functional tests. Researchers will track safety and side effects throughout the 36 weeks to better understand the treatment's impact and tolerability.

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Researchers are evaluating the safety and effectiveness of a carotid artery stent system in patients with carotid artery stenosis who have high-risk features for carotid endarterectomy. This prospective, multicenter, single-group study is being conducted at about 10 interventional neurology centers in China and involves using a stent system provided by Shanghai HeartCare Medical Technology Co., Ltd. The primary goal is to monitor for stroke, heart attack, or death within 30 days after the procedure and ischemic stroke in the treated artery area between 31 and 365 days post-procedure. The study uses a carotid artery stent system made of a nitinol self-expanding stent delivered by a device designed to accommodate a guidewire. Eligible patients undergo the stenting procedure to treat narrowing in the carotid artery or its branches. There are no comparison groups, as this is a single-group study focusing on evaluating the device's performance in patients considered high-risk for traditional surgery. Participants will be closely followed for up to one year after their procedure. Researchers will assess outcomes such as stroke, heart attack, and death during this period. Evaluations include imaging studies like carotid ultrasound and angiography before and during the procedure. The study also involves regular safety monitoring and collecting data on any adverse events. Participants provide informed consent and agree to attend follow-up visits as scheduled.

Researchers are collecting data on 10,000 patients aged 12 years and older with primary headache disorders and medication-overuse headache in the China HeadAche DIsorders RegiStry (CHAIRS). The study examines biomarkers, brain imaging features, cognitive abilities, genetic characteristics, social and demographic details, medical history, treatments used, and outcomes related to headache disorders, with planned long-term follow-up. Participants include groups with episodic migraine, chronic migraine, medication-overuse headache, new daily persistent headache, and other primary headache types. Some participants receive behavioral follow-up, while others using medications like Yangxue Qingnao Granules or biological treatments such as eptinezumab or erenumab are observed during a 12-week period where treatment decisions and dosing are made by their physicians as part of routine care. Throughout the study, participants undergo assessments including headache frequency, brain MRI changes, cognitive tests like the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Exam (MMSE), genetic analysis, and evaluations of disability, anxiety, and depression over long-term periods up to 10 years. Short-term outcomes such as pain relief two hours after medication are also measured. Follow-up visits may continue annually after the initial 24 months, with data collected during routine clinical visits.