Nan Yang Shi

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are evaluating the safety and early effects of IMC-001 injections to improve the stability of atherosclerotic plaques in patients who have acute coronary syndrome, which includes conditions like acute myocardial infarction or unstable angina. This early phase 1, two-center, randomized, double-blind, placebo-controlled study involves adults aged 18 to 75 years. The goal is to see if IMC-001, given alongside standard medical treatment, can reduce the amount of unstable plaque in coronary arteries compared to a placebo. Participants will be divided into two dose groups, each with 9 subjects: 6 receiving IMC-001 plus optimal medical care and 3 receiving a placebo plus optimal medical care. The injection is given while patients continue guideline-based treatments for coronary artery disease. The study includes monitoring plaque changes using coronary computed tomography angiography (CCTA) at the start and six months after treatment. Throughout the study, participants will undergo imaging scans and laboratory tests to assess changes in plaque volume and inflammation markers. Researchers will track safety and plaque stability over a 6-month period after treatment. Participants will also follow contraception guidelines if applicable during the study and for six months afterward. The study aims to measure the volume of low-attenuation plaque in coronary arteries as the main outcome at day 176 after starting treatment.

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

Researchers are evaluating the safety, tolerability, and effectiveness of RC278 in treating patients with locally advanced unresectable or metastatic malignant solid tumors. This Phase I/II clinical trial aims to find the maximum tolerated dose and recommended dose for Phase 2, while also assessing side effects and tumor response. Participants will receive RC278 through intravenous infusion every three weeks. Treatment will continue until unacceptable side effects occur, the disease progresses, or the participant withdraws. The study includes a dose escalation period to determine optimal dosing and an evaluation period to monitor effects at the recommended dose. Throughout the 24-month study, participants will undergo regular monitoring for dose-limiting toxicities, adverse events, and effectiveness of treatment using imaging and clinical assessments following RECIST v1.1 criteria. Safety and response rates will be closely tracked to inform future research and treatment strategies.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

This research aims to evaluate the effectiveness and safety of early treatment with BXOS110 injection in patients who have experienced an acute ischaemic stroke within 3 hours of symptom onset. The trial is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to clarify how well BXOS110 reduces overall disability after stroke compared to placebo. Participants include adults diagnosed with acute ischaemic stroke meeting specific neurological criteria. Participants are randomly assigned in equal numbers to receive either an intravenous infusion of BXOS110 at a dose of 3.0 mg/kg (up to a maximum of 300 mg) or a placebo infusion of the same volume and dose. The study consists of a screening and baseline period where consent and eligibility are confirmed within 3 hours of stroke onset, followed by a treatment phase where the assigned infusion is administered. Afterwards, participants enter a follow-up period with evaluations at Day 2, Day 3, Day 10 or discharge (whichever comes first), Day 30, and Day 90 after treatment. Throughout the study, participants will undergo assessments to monitor efficacy and safety, including the primary outcome of the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at Day 90, indicating reduced disability. Neurological status, adverse events, and overall health will be evaluated during scheduled visits. The total duration of participation spans from initial screening through the 90-day follow-up, with close monitoring to understand the impact of BXOS110 on stroke recovery.

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.

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 of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.