Lianyungang

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the real-world effectiveness and safety of Trastuzumab Deruxtecan (T-DXd) in Chinese patients with unresectable or metastatic HER2-positive or HER2-low breast cancer. This multi-center prospective observational study focuses on patients who have previously received anti-HER2 therapies or systemic therapies in the metastatic setting, or those with disease recurrence shortly after adjuvant chemotherapy. The study aims to understand the time to next treatment or death, treatment patterns, patient characteristics, and safety in a real-world setting over a 36-month period. Participants will receive Trastuzumab Deruxtecan via intravenous infusion, starting treatment no more than 14 days before enrollment. The study includes patients with confirmed HER2-positive or HER2-low status who meet specific prior treatment criteria. Participants are followed from the day they begin T-DXd until the study ends, death, withdrawal, loss to follow-up, or study closure, whichever comes first. During the study, researchers will collect clinical data and patient-reported outcomes, including safety events reported by physicians and patient tolerability. The main measurement is the real-world time to next treatment or death. Additional assessments include time to treatment discontinuation, management of side effects, and patient questionnaires when possible. This comprehensive monitoring helps evaluate the overall impact of T-DXd treatment in this patient population.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment period.

Researchers are conducting a multicenter Phase Ib/II study to evaluate the safety, tolerability, and preliminary effectiveness of HB0025 combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) and advanced endometrial cancer (EC). The trial includes two phases: a dose escalation phase to determine the maximum tolerated dose and dose-limiting toxicities, and a dose expansion phase to assess the efficacy and safety of selected doses in larger patient groups. In the dose escalation phase, HB0025 is given intravenously every 3 weeks at varying doses (6 to 30 mg/kg) combined with fixed chemotherapy regimens depending on the cancer type. For non-squamous NSCLC, HB0025 is combined with pemetrexed and carboplatin; for squamous NSCLC and endometrial cancer, it is combined with paclitaxel and carboplatin. After initial cycles, patients may continue maintenance treatment with HB0025 plus pemetrexed or HB0025 alone until intolerable toxicity, disease progression, or other study endpoints occur. The dose expansion phase enrolls about 40 patients per cohort at selected doses to further evaluate treatment safety and preliminary response. Participants will undergo multiple treatment cycles with scheduled assessments including tumor measurements by RECIST 1.1 criteria, safety monitoring, laboratory tests, and evaluation of response over up to 24 months. The primary outcome measured is the objective response rate. Patients are monitored closely for adverse effects throughout treatment and maintenance until disease progression, withdrawal, or study completion. This study aims to better understand the potential of HB0025 combined with chemotherapy in treating these advanced cancers.

Researchers are evaluating the safety and effectiveness of the J-VALVE Transfemoral Aortic Valve system compared to traditional surgical aortic valve replacement in patients with severe aortic regurgitation (grade 3 or higher). The trial focuses on patients aged 65 years or older who have symptomatic or certain asymptomatic severe aortic regurgitation with evidence of left ventricular function impairment, aiming to establish which treatment approach works better for this condition. Participants will receive either the J-VALVE transcatheter aortic valve replacement (TAVR) or a commercially available surgical biological aortic valve replacement device (SAVR). The treatments involve either a catheter-based procedure using the J-VALVE system or conventional surgery with a biological valve implant. Suitability for both procedures is assessed by a multidisciplinary heart team before enrollment. Throughout the study, participants will be followed for 12 months to monitor outcomes including all-cause mortality, all stroke events, and unplanned cardiac rehospitalizations. Researchers will conduct regular evaluations and follow-up visits to track health status and any complications. Participants agree to comply with all post-procedure visits to support comprehensive safety and efficacy assessments over the study period.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of an investigational treatment called RD06-05 in adults with several active autoimmune diseases. These diseases include systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), and myasthenia gravis (MG). This is an early phase 1 open clinical pharmacological translational research study designed to gather important information on this novel therapy for these conditions. The treatment involves a CAR T-cell therapy known as RD06-05 administered through an intravenous injection following a preparatory regimen of lymphodepleting therapy using fludarabine and cyclophosphamide. Participants receive this targeted cellular therapy aimed at specific immune system components. The study does not describe additional treatment groups or placebo comparators, focusing instead on monitoring this therapy's effects in the patient population. During the 2-year study period, researchers closely monitor participants for adverse events, including treatment-emergent and serious adverse events, to evaluate safety. Patients undergo regular assessments including laboratory tests and evaluations of organ function to ensure eligibility and ongoing safety. The study also tracks pharmacokinetic and pharmacodynamic responses to understand how the treatment behaves in the body and its biological effects. Participants are followed over time to collect comprehensive safety and efficacy data throughout the study duration.

Researchers are evaluating the effectiveness and safety of TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP) to block its pathway and reduce inflammation. The study focuses on adults aged 18 to 75 years with chronic rhinosinusitis and nasal polyps (CRSwNP), a condition involving persistent nasal symptoms and polyps in both nostrils. This is a Phase III clinical trial designed to assess improvements in nasal polyp size and nasal congestion over 24 weeks. Participants will be randomly assigned to receive either TQC2731 injection or a placebo. The study involves monitoring the nasal polyp score (NPS) and nasal congestion score (NCS) from baseline through 24 weeks to evaluate changes. Both groups will continue using a stable dose of intranasal corticosteroids during the study. The trial is double-blind and placebo-controlled, ensuring that neither participants nor researchers know which treatment is given. During the study, participants will undergo nasal endoscopy to assess polyp size and daily or weekly symptom scoring for nasal congestion. Researchers will track adherence to nasal spray use and symptom recording through electronic diaries. Safety will be monitored throughout, and participants will be followed for 24 weeks to measure changes in nasal polyp and congestion scores as primary outcome measures.