Fukuyama

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

Researchers are evaluating how well elritercept works compared to epoetin alfa in treating anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who need regular red blood cell (RBC) transfusions. The study aims to see if elritercept can reduce the need for RBC transfusions, improve tiredness without transfusions, lower transfusion burden, and enhance quality of life. It also examines the immune response to elritercept and monitors its safety. Participants receive either elritercept or epoetin alfa as subcutaneous injections. The study is a phase 3, multicenter, randomized trial comparing the efficacy and safety of these two drugs. The treatment period lasts through 24 weeks, with each cycle lasting 28 days. Researchers monitor participants for RBC transfusion independence lasting at least 12 weeks and a significant increase in hemoglobin levels. During the study, participants undergo regular assessments including blood tests to measure hemoglobin and other blood counts. Researchers track transfusion needs and quality of life reports. Safety is carefully monitored throughout the trial. Participants are involved from screening through 24 weeks of treatment, with evaluations to measure the effectiveness of the treatments and any side effects.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years who have severe uncontrolled asthma. These children must be on medium to high doses of inhaled corticosteroids along with at least one other asthma controller medication, with or without oral corticosteroids. This phase 3, multicenter, double-blind, placebo-controlled study aims to better understand how tezepelumab affects asthma control in this pediatric population. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo for 52 weeks during the double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in phase. After the treatment period, a 12-week follow-up phase occurs without treatment. Eligible participants can then join an optional open-label extension, receiving tezepelumab for an additional 104 weeks followed by another 12-week post-treatment follow-up. Throughout the study, participants will have regular assessments including lung function tests, asthma control questionnaires, and monitoring for asthma exacerbations. Researchers will measure the annualized rate of severe asthma flare-ups from the start of treatment to week 52. Safety and treatment adherence will also be closely monitored during all study phases, with total participation potentially extending over two years for those in the extension period.

Researchers are evaluating the safety and effectiveness of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease (PAD), a condition causing pain and difficulty walking due to narrowed arteries. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how orforglipron affects walking ability and overall safety in people with this condition. Participants will be involved in the study for about 58 weeks. Participants will receive either orforglipron or a placebo, both administered orally once daily. The study includes a comparison between these two groups to assess the impact of orforglipron on walking distance and other health outcomes over the course of the trial. During the study, researchers will measure changes in the maximum distance participants can walk compared to their baseline, particularly at the start and after 52 weeks of treatment. Participants will be monitored for safety and any side effects throughout the study. The total duration of participation is approximately 58 weeks, allowing for thorough evaluation of the treatment's effects and safety.

Researchers are investigating whether a combination of antiplatelet drugs works as well as intravenous tissue plasminogen activator (rt-PA) in treating small ischemic strokes known as lacunar strokes. This phase 4 trial aims to determine if the dual antiplatelet therapy is not inferior to the current standard rt-PA treatment and if it reduces bleeding complications compared to rt-PA. Participants will receive either a low-dose rt-PA treatment (0.6 mg/kg alteplase) or a dual antiplatelet therapy consisting of aspirin 200 mg and clopidogrel 300 mg. Treatment is given during the hyperacute phase of stroke, within 4.5 hours of symptom onset. The study compares these two approaches to assess their effectiveness and safety. During the study, participants will be monitored for neurological status three months after their stroke. Assessments may be conducted in person, by phone, or by mail. The main outcome measured is the proportion of participants achieving an excellent outcome three months post-stroke. Safety and treatment effects will be closely observed throughout the trial.

Researchers are investigating the effects of quizartinib compared to a placebo, both combined with chemotherapy, in adults newly diagnosed with FLT3-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). This phase 3 clinical trial focuses on overall survival as the primary outcome and involves testing participants for FLT3-ITD mutation status at a central laboratory using a validated assay. Participants will receive either quizartinib or placebo at a dose of 60 mg taken orally once daily. Both groups will also receive standard induction and consolidation chemotherapy using cytarabine and an anthracycline (daunorubicin or idarubicin). After chemotherapy, quizartinib or placebo will be administered as maintenance therapy for up to 36 cycles. During the study, participants will be monitored for overall survival up to approximately 42 months from when the first patient is randomized to reach the target number of deaths. The study involves regular assessments including treatment monitoring and safety evaluations throughout the induction, consolidation, and maintenance phases to evaluate the effect of quizartinib in this patient population.

This research aims to observe the safety and effectiveness of dabrafenib and trametinib in patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors, excluding colorectal cancer. It is a prospective, multicenter, single-arm, non-interventional observational study conducted through a central registration system using electronic data capture. The study includes both adult and pediatric patients, with long-term monitoring planned to collect comprehensive safety data. Patients already prescribed Tafinlar/Mekinist (dabrafenib and trametinib) before joining the study will be enrolled without treatment allocation or changes. The study targets 65 adult patients for effectiveness analysis and approximately 20 pediatric patients. Pediatric patients will be observed for up to 8 years after starting treatment to gather long-term information, while adult patients will be followed for one year post-treatment initiation. During participation, patient safety and treatment response will be monitored through reports of adverse events and overall response rates. Pediatric patients will have ongoing safety assessments related to skeletal and sexual development over the 8-year period. Adults will have their treatment response evaluated over one year. Data collection includes long-term follow-up regardless of treatment discontinuation, aiming to provide comprehensive post-marketing surveillance information on these medications.

This research observes patients with Paroxysmal Nocturnal Hemoglobinuria who are treated with Fabhalta capsules. It is a multicenter, single-arm, non-interventional study designed to monitor drug use and safety over time. The study uses a central registration and all-case surveillance system to collect data. Participants will be observed for 48 weeks after starting Fabhalta treatment. If treatment stops within this period, any adverse events and use of other medications will be tracked up to 30 days after the last treatment day. There are no additional interventions or comparison groups in this study. During the study, researchers will monitor the occurrence of infections and other adverse events through case report forms. Participants' health and drug usage will be recorded throughout the observation period. The total participation lasts for 48 weeks, focusing on safety and drug use in real-world settings.

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.