Zhumadian

Researchers are evaluating the safety and effectiveness of rilzabrutinib compared to placebo in adults with active Immunoglobulin G4 Related Disease (IgG4-RD). This Phase 3, randomized, double-blind study aims to measure the time until the first IgG4-RD clinical disease flare during a 52-week treatment period. Additional goals include assessing disease control, flare-free rates, use of glucocorticoid rescue, and monitoring safety through adverse events, laboratory tests, and electrocardiograms. Participants will be randomly assigned to receive either oral rilzabrutinib tablets or placebo for 52 weeks. Glucocorticoids may be used as rescue medication if needed. The study includes a screening period lasting 4 to 6 weeks before treatment begins, followed by the 52-week double-blind treatment phase, and a 2-week follow-up after treatment. An optional open-label extension lasting up to 108 weeks is also available for participants. During the study, participants will attend 16 visits for assessments, which may include clinical evaluations, imaging tests such as CT, MRI, PET, or ultrasound to monitor disease activity, and laboratory tests. Researchers will track time to disease flare and collect data on flare-free rates, safety parameters, and medication use. Participants' vaccination status and contraceptive use will be monitored according to local guidelines, and overall study participation could last up to 60 weeks or longer if joining the extension phase.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness and safety of brenipatide when given along with standard care compared to a placebo with standard care in adults with bipolar disorder. This Phase 2 study aims to see if brenipatide can delay the worsening of bipolar symptoms. The trial includes participants aged 18 to 75 years and involves a careful assessment of how well the treatment works and its safety profile. The trial has three main periods: a screening period lasting about one month, a treatment period of at least six months, and a follow-up period of around two months. Participants receive either brenipatide or placebo, both given by subcutaneous injection, alongside their usual bipolar disorder medications. The study may end earlier if symptoms worsen or if participants withdraw for any reason. Participants will be asked to self-inject the study medication, maintain diaries, complete questionnaires, and attend regular visits throughout the study. Researchers will monitor the time to relapse, defined as the number of days from randomization until symptoms worsen according to specific criteria, over at least six months. Safety and adherence to treatment will also be closely observed during the study.

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are evaluating the safety and effectiveness of brenipatide combined with standard care compared to a placebo with standard care in adults with schizophrenia. This phase 2 study aims to understand how well brenipatide works as an additional treatment for schizophrenia and monitor any side effects. Participants eligible for the study must have schizophrenia and be on stable standard care medication. The trial consists of three main periods: a screening period lasting about one month, a treatment period that can last up to 12 months, and a follow-up period of approximately two months. During the treatment phase, participants receive either brenipatide or placebo administered by subcutaneous injection alongside their standard care. The study includes careful monitoring and adherence to study procedures such as self-injection, keeping diaries, and completing questionnaires. Participants will be involved in regular visits and assessments throughout the entire study duration, which may last up to 15 months. Researchers will measure changes in body weight from baseline to week 52 as a primary outcome. Participants will also be monitored for safety and efficacy through ongoing evaluations, including the use of electronic or paper diaries and required questionnaires to track their progress and response to treatment.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

Researchers are investigating whether Extract of Ginkgo Biloba Leaves Tablets can help improve thinking and memory in people aged 55 years and older who have had an ischemic stroke, which is caused by a blocked blood vessel in the brain. This phase 4 clinical trial is designed to assess both the effectiveness and safety of this treatment when added to the usual care for stroke recovery. Participants must have had a mild stroke confirmed by an MRI scan and show signs of cognitive impairment. The study takes place at multiple hospitals across China. Participants will be randomly assigned to one of two groups: one group will receive Extract of Ginkgo Biloba Leaves Tablets at a dose of 240 mg daily, divided into three doses of two 40 mg tablets each, along with their standard post-stroke care for 52 weeks. The other group will receive only the standard care recommended by the Chinese Stroke Association. The trial is open-label, meaning both the researchers and participants know which treatment is given. Throughout the year-long study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and testing. Researchers will evaluate changes in cognitive function using tests such as the Montreal Cognitive Assessment, Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency Test. They will also monitor neurological impairment and any new stroke events. Follow-up phone calls will occur at 12 and 38 weeks to support ongoing monitoring and safety assessments.

Researchers are evaluating the efficacy and safety of SAR441566, an oral tablet medication, in adults with moderate-to-severe ulcerative colitis (UC). This Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study aims to determine how well different doses of SAR441566 help patients achieve clinical remission, measured by the modified Mayo Score, after 12 weeks of treatment. The study includes a screening period lasting up to 28 days plus an additional 7 days if needed. The main treatment period lasts 52 weeks and consists of a 12-week double-blind induction phase followed by a 40-week maintenance phase, ending with a 2-week follow-up after treatment. Participants receive either SAR441566 or a matching placebo orally as tablets. After the main study, eligible participants not joining a long-term study may enter an open-label treatment period for up to 40 weeks. The main study involves 12 visits, and the open-label phase includes 8 visits. During the study, participants will be monitored through clinical assessments and scoring of disease activity. Researchers will track remission rates at week 12 and evaluate long-term safety and efficacy during the maintenance and open-label periods. The total time involved for participants can be up to 59 weeks, including screening, treatment, follow-up, and optional open-label extension.

Researchers are evaluating the effectiveness of riliprubart compared to the usual treatment of intravenous immunoglobulin (IVIg) in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who are already receiving maintenance IVIg treatment. This Phase 3 study aims to assess how well riliprubart works and its safety in this population. Participants must meet specific CIDP diagnostic criteria and have a history of responding to IVIg treatment. The study involves administering riliprubart or placebo through intravenous (IV) or subcutaneous (SC) solutions, alongside the usual IVIg treatment. The treatment phase includes a randomized, double-blind comparison of riliprubart versus IVIg, followed by an open-label extension period for continued evaluation. The entire study lasts up to 109 weeks, encompassing screening, treatment, and follow-up phases. Participants will have regular assessments to monitor their response to treatment, including measurements of disability and disease activity scores. Researchers will track the percentage of participants showing a response from baseline to week 24 and those maintaining response through week 48 during the extension. Safety and long-term effects will also be observed throughout the study duration, ensuring comprehensive monitoring of participant health and treatment outcomes.

Primary liver cancer, particularly hepatocellular carcinoma (HCC) at BCLC stage C, is a common and serious cancer where many patients are not eligible for surgery due to advanced disease. Researchers are evaluating the effectiveness and safety of two treatments: drug-eluting bead transarterial chemoembolization (DEB-TACE) alone versus DEB-TACE followed by hepatic artery infusion chemotherapy (HAIC). This study aims to see if combining these treatments provides better outcomes for patients with unresectable advanced liver cancer. The trial compares two groups: one receiving DEB-TACE alone and the other receiving DEB-TACE followed by sequential HAIC using a FOLFOX-based chemotherapy regimen. DEB-TACE uses drug-loaded beads to block tumor blood supply and release chemotherapy slowly, while HAIC delivers chemotherapy directly into the liver artery. This combination is designed to enhance the anti-tumor effect while potentially reducing side effects. Treatment is administered in a multi-center setting with careful monitoring. Participants will be monitored from the first DEB-TACE treatment up to 36 months or until disease progression or death. Assessments include imaging scans to evaluate tumor response according to mRECIST criteria, laboratory tests, and safety evaluations. Researchers will measure progression-free survival, which is the time without tumor growth or death. Participants must cooperate with treatment, complete scheduled visits, and provide informed consent, with an estimated life expectancy of at least 3 months.