Yamaguchi

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.

Researchers are evaluating the safety and clinical effects of Awiqli Insulin Icodec in people with diabetes mellitus in Japan through a non-interventional observational study. The study focuses on real-world use of Awiqli prescribed by doctors as part of routine clinical care, with no restrictions on diabetes type or prior treatments. This research aims to gather information about adverse reactions and clinical outcomes over a one-year period. Participants will receive commercially available Awiqli once weekly, with treatment decisions made by their doctors following normal clinical practice. The study does not assign treatment but observes patients using Awiqli as prescribed. Data will be collected throughout the 52-week period to monitor safety and clinical parameters under real-world conditions. During the study, participants will be monitored for adverse reactions, serious adverse events, and changes in blood sugar control, including glycosylated hemoglobin HbA1c and fasting plasma glucose. Quality of life related to diabetes therapy will also be assessed. The study involves regular data collection over approximately one year, and participants continue with their usual care while contributing information to the study.

Researchers are conducting a survey to study patients who have received Ondexxya Intravenous Injection 200 mg to neutralize the anticoagulant effects of Factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. This observational study aims to monitor safety specifications such as thrombotic events, infusion reactions, and re-bleeding, while also understanding the drugs safety and effectiveness under real-world use. The survey collects information about the occurrence of unknown adverse drug reactions, the incidence of adverse reactions during routine use, and factors that might influence the drugs safety or effectiveness. There are no specific treatments or interventions administered as part of the study since it observes patients receiving routine care with Ondexxya. Participants will be monitored for 30 days to document adverse drug reactions and safety-related events, including how patient background factors may affect outcomes. Data collection involves safety and effectiveness information gathered during this period, with no additional procedures or visits beyond standard clinical care. The study is sponsored by AstraZeneca and will continue until October 2026.

Researchers are evaluating the efficacy and safety of ONO-2017 cenobamate combined with other antiepileptic drugs in Japanese patients who have primary generalized tonic-clonic seizures. This phase III, open-label study focuses on patients aged 12 years or older who experience frequent generalized seizures as part of idiopathic generalized epilepsy. Participants will take cenobamate orally once daily alongside one to three other fixed-dose antiepileptic medications. The study aims to observe changes in seizure frequency over a 12-week maintenance period while monitoring safety and tolerability. Throughout the study, researchers will track seizure frequency and reduction rates using 28-day intervals during the maintenance phase. Participants will be assessed regularly for seizure control and any side effects. The study will continue until January 2027, allowing for ongoing evaluation of treatment effects and safety.

Researchers are evaluating the safety and effectiveness of JX10 compared to a placebo in adults aged 18 to 90 who have experienced an acute ischemic stroke and present for care between 4.5 to 24 hours after stroke onset. The study aims to determine if JX10 improves functional outcomes measured by the modified Rankin Scale and to assess the risk of symptomatic intracranial hemorrhage. This is a multicenter, double-blind, randomized, placebo-controlled study sponsored by Corxel Pharmaceuticals, conducted in phases 2 and 3. Participants in Part 1 are randomly assigned to receive either JX10 at doses of 1 mgkg or 3 mgkg, or a placebo. In Part 2, participants receive the optimal JX10 dose selected from Part 1 or a placebo. The treatment involves intravenous administration of a thrombolytic agent, JX10, designed to improve blood flow by dissolving clots. The study uses a quadruple masking design to ensure unbiased results. Throughout the study, participants will be monitored and assessed for functional recovery using the modified Rankin Scale at 90 days, with safety evaluations including the incidence of symptomatic intracranial hemorrhage within 36 hours post-treatment. Additional assessments include adverse events, serious adverse events, and major bleeding occurrences within 24 hours and up to 14 days after treatment. Total participation spans at least 90 days, during which clinical and radiographic evaluations will be conducted to track progress and safety.

Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.

Researchers are studying the safety, tolerability, pharmacokinetics, and pharmacodynamics of ION717, delivered through intrathecal injection, in people with prion disease. This is a first-in-human, multi-center study that includes participants with early-stage prion disease. The trial aims to understand how the body handles ION717 and how the drug affects prion protein levels. The study includes three regimens. Regimens 1 and 2 involve a 30-week double-blind treatment period where participants receive multiple doses of ION717 and placebo in a blinded order, followed by a 142-week open-label extension where all participants receive ION717. Regimen 3 is an open-label phase during which participants receive multiple doses of ION717 throughout both the 30-week treatment and 142-week extension periods. The study also includes a 32-week post-treatment follow-up. Participants will be involved for up to about 5 years, including screening, treatment, extension, and post-treatment periods. Assessments include monitoring for adverse events, measuring drug levels in plasma and cerebrospinal fluid, urine analysis, and tracking changes in prion protein concentrations. Safety and tolerability are closely monitored throughout the study, particularly during the initial 33 weeks. The study collects detailed pharmacokinetic and pharmacodynamic data to evaluate the effects of ION717.