Nagano

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of a drug called S230815 in children aged 2 to 12 years who have Developmental Epileptic Encephalopathy caused by specific genetic changes in the KCNT1 gene. This is a Phase Ib/II, first-in-human, multicenter, open-label study focusing on this rare and severe form of epilepsy. The study includes two main parts. Part 1 involves giving participants increasing doses of S230815 through injection to determine the best dose. After completing Part 1, participants may enter Part 2, a long-term extension where they continue receiving their assigned dose of S230815 for up to 72 weeks. Participants will be closely monitored throughout the study for side effects and drug levels. Researchers will collect safety information, including any adverse events, for up to 116 weeks. Genetic testing confirms eligibility, and participants will undergo various assessments during the screening and treatment periods to evaluate the drug's effects and safety over time.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Researchers are evaluating whether baricitinib can delay the onset of clinical stage 3 type 1 diabetes (T1D) in children and adults at high risk of developing the disease. This phase 3, double-blind, randomized, placebo-controlled study includes participants aged 1 to under 36 years who have early stages of T1D or multiple diabetes-related autoantibodies indicating increased risk. The study aims to measure the time from the start of the trial to diagnosis of stage 3 type 1 diabetes, with participation lasting up to approximately 5 years. Participants will be randomly assigned to receive either baricitinib or a placebo, both administered orally. The trial compares these two groups to assess the impact of baricitinib on delaying progression to stage 3 T1D. The study's design includes careful monitoring of participants over time to evaluate the effects of the medication or placebo on disease development. During the study, participants will undergo regular assessments to detect the progression of diabetes, including laboratory tests for autoantibodies and clinical evaluations. Researchers will track the time it takes for participants to develop stage 3 T1D, along with monitoring safety and any adverse effects. The total duration of participation can be up to 5 years, ensuring thorough observation of long-term outcomes related to the study interventions.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are assessing the effectiveness and safety of ONO-2020 in Japanese patients who experience agitation linked to Alzheimer's Disease dementia. This phase 2a study focuses on patients aged 55 to 90 years with probable Alzheimer's, who show specific agitation symptoms and cognitive impairment as measured by standard scales. The goal is to better understand how ONO-2020 may impact agitation in this population. Participants will be randomly assigned to receive either ONO-2020 or a placebo. Those in the ONO-2020 group will take two tablets by mouth once daily. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo during the trial. Treatment and evaluation periods will extend up to 16 weeks. During the study, participants will undergo various assessments including changes in agitation scores, safety monitoring through vital signs and electrocardiograms, and laboratory tests. Researchers will also track adverse events and monitor for suicidal thoughts or behaviors using a specific rating scale. The study includes hospitalization during treatment to ensure participant safety and close observation throughout the trial period.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are evaluating the effectiveness and safety of a combination treatment of follitropin alfa and lutropin alfa compared to hMG in Japanese women with luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency who are undergoing assisted reproductive technology (ART). This Phase 3 study focuses on women wishing to conceive and aims to improve follicular development in this specific group with infertility issues. The study duration is approximately 5.5 months for those who do not become pregnant and up to 13 months for participants who confirm pregnancy in Part A. Participants will be assigned to receive either a fixed dose combination of follitropin alfa and lutropin alfa administered subcutaneously once daily, starting at 150 IU of follitropin alfa and 75 IU of lutropin alfa, or hMG given at 150 IU subcutaneously daily. Both treatments continue for up to 18 days during ovarian stimulation. Additional medications include daily injections of 250 mcg Cetrorelix acetate from Day 5 or 6 until the day of r-hCG, which is administered subcutaneously at 250 mcg for final follicular maturation. After oocyte retrieval, participants will self-administer 90 mg of progesterone gel intravaginally daily for luteal phase support. During the study, participants will undergo vaginal ultrasound scans to confirm ovarian status and antral follicle count, semen analysis of their male partners, and cervical cytologic tests to ensure eligibility. The main outcome measured is the total number of oocytes retrieved approximately 36 to 38 hours after r-hCG administration (Day 4). Researchers will monitor participants for treatment safety and efficacy throughout the study periods, with follow-ups depending on pregnancy status, ensuring comprehensive assessment over the full duration of participation.

Transthyretin amyloidosis (ATTR) is a condition where the transthyretin (TTR) protein breaks down and forms amyloid plaques that build up in organs, causing damage. This can happen either as people age (wild-type ATTR) or due to inherited defective TTR genes (variant ATTR). When amyloid deposits affect the heart, it leads to transthyretin amyloid cardiomyopathy (ATTR-CM), and when it affects nerves, it causes transthyretin amyloid polyneuropathy (ATTR-PN). Researchers are evaluating acoramidis, a drug designed to stabilize the TTR protein to prevent or delay these conditions in adults who carry a pathogenic TTR gene variant but do not yet show symptoms. The study is a Phase 3, randomized, double-blind, placebo-controlled trial involving asymptomatic adults aged 18 to 75 years who carry a known pathogenic TTR variant. Participants receive either acoramidis or a placebo pill taken orally twice daily. Participants are selected based on their age being within 10 years younger or older than their predicted age of disease onset, which is estimated from family history or published data. The study aims to prevent or delay the development of ATTR-CM or ATTR-PN over approximately 7 years. Participants will be closely monitored throughout the study period for the time to development of ATTR, either cardiomyopathic or polyneuropathic forms, as determined by central adjudication. Assessments include genetic testing confirmation, cardiac magnetic resonance testing, and evaluation for any signs of disease progression. Safety and treatment adherence will also be monitored. The study may last up to 7 years or until it is declared over, with careful follow-up to detect any early signs of disease or treatment effects.

Crohn's disease is a chronic inflammatory condition affecting the digestive tract that currently has no cure. This research aims to evaluate the safety and effectiveness of upadacitinib in treating moderate to severe active Crohn's disease in a real-world setting in Japan. The study will monitor any adverse events and changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their doctors following local approved guidelines. Around 240 participants will be enrolled, and treatment will be according to each participant's usual clinical care. The study is observational and non-interventional, meaning no additional treatments or procedures beyond standard care will be required. Participants will be followed for up to 64 weeks, with study visits conducted either in person or virtually according to standard care practices. Researchers will assess safety by tracking serious infections related to the drug and monitor disease activity throughout the study period. There is expected to be no extra burden on participants beyond their routine care and assessments.