Yan Bian Chao Xian Zu Zi Zhi Zhou

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are evaluating the effectiveness of BDB-001 injection combined with cyclophosphamide followed by azathioprine, or combined with rituximab, in inducing remission for patients with active ANCA-associated vasculitis AAV. This phase III clinical trial aims to determine how well these treatments work in comparison to standard therapy with prednisone, focusing on disease remission and safety. Participants will be randomly assigned to receive either BDB-001 injection plus cyclophosphamideazathioprine or rituximab with a prednisone placebo, or a prednisone treatment combined with cyclophosphamideazathioprine or rituximab and a placebo matching BDB-001. All treatments are administered intravenously. The study evaluates disease remission at 24 weeks and sustained remission, relapse rates, kidney function changes, glucocorticoid toxicity, and quality of life over 48 weeks. Throughout the trial, participants will have regular assessments including measurements of disease activity using the Birmingham Vasculitis Activity Score BVAS, kidney function tests, and quality of life questionnaires. Safety and treatment effects will be monitored closely. Total participation lasts up to 48 weeks, with the main outcome measured at 24 weeks to determine remission status.

Researchers are studying the effects and safety of SR1375 in hospitalized adults with community-acquired pneumonia CAP. This phase 2, randomized, double-blind, placebo-controlled study aims to evaluate SR1375 compared to placebo in patients who have not improved after initial standard pneumonia treatment. The study includes adults aged 18 to 85 years and is sponsored by Shanghai SIMR Biotechnology Co., Ltd. Participants will be randomly assigned to one of four groups to receive either 0.3 mg, 1 mg, or 3 mg of SR1375 capsules or a placebo daily by mouth for 8 weeks, alongside their usual pneumonia treatments. The study includes a screening period, an 8-week double-blind treatment period, and a 14-day safety follow-up after treatment ends. During the study, participants will undergo assessments including the NIAID-OS 8-point scale to monitor pneumonia severity, oxygen levels, and other health measures up to 56 days. Researchers will track outcomes such as oxygenation, mortality, hospitalization duration, and readmission rates. The total participation time for each patient is up to 10 weeks, with close monitoring of safety and health status throughout the study.

This research aims to compare the effects of two inhalers, budesonidealbuterol metered-dose inhaler BDA MDI and albuterol sulfate metered-dose inhaler AS MDI, both used as needed, in adolescents aged 12 to 17 years with asthma. The study focuses on their impact on the annual rate of severe asthma attacks in participants who have a documented diagnosis of asthma and at least one severe exacerbation in the past year. This is a randomized, double-blind, multicenter Phase IIIb trial. Participants are randomly assigned in equal numbers to receive either BDA MDI 160180 micrograms 2 puffs of 8090 micrograms or AS MDI 180 micrograms 2 puffs of 90 micrograms as needed, alongside their usual maintenance asthma therapy. The study includes a 7 to 28-day screening period, a 52-week treatment period, and a safety follow-up lasting 7 to 14 days after treatment ends. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered at a separate visit after safety follow-up. During the study, participants will be monitored through regular assessments including lung function tests such as peak expiratory flow, evaluation of asthma exacerbations, and safety checks for adverse events. The main outcome measured is the annualized rate of severe asthma exacerbations over the 52-week treatment. Safety follow-up and pharmacokinetic evaluations will further assess drug concentrations and participant well-being. Overall participation lasts from screening through safety monitoring after treatment completion.

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.

Researchers are evaluating the long-term safety, effectiveness, and immune response of two doses of TQH2722 injection in adults with severe chronic sinusitis, with or without nasal polyps. This Phase II, multicenter, randomized trial aims to expand understanding of TQH2722s role in managing this condition over an extended period. Participants receive either 300mg or 600mg of TQH2722 injection every two weeks until week 22, combined with daily use of Mometasone furoate nasal spray at doses of 100-200 mcg until week 32. The study includes two parts A and B, with similar treatment schedules and follow-up visits to monitor the treatment effects. During the study, participants undergo regular assessments including monitoring for treatment-emergent adverse events up to 32 weeks. Researchers measure changes in sinus imaging scores, smell identification tests, symptom scores, nasal polyp sizes, and immune responses. Safety evaluations include laboratory tests and monitoring for serious adverse events. The total study duration includes treatment and follow-up visits over approximately 32 weeks.