Toyama

Researchers are evaluating the effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are evaluating the efficacy, safety, and tolerability of two dosing regimens of itepekimab compared to placebo as an add-on treatment to intranasal corticosteroids in adult men and women with chronic rhinosinusitis with nasal polyps (CRSwNP). This multinational, randomized, double-blind, placebo-controlled Phase 3 study includes participants aged 18 years and older who have inadequately controlled CRSwNP. The study aims to better understand how these treatments impact nasal polyp symptoms and disease control over a one-year period. Participants will be randomly assigned to receive one of two dosing regimens of itepekimab or a placebo, all administered by subcutaneous injection. All participants will continue using mometasone furoate nasal spray as standard intranasal corticosteroid therapy. Treatment will last up to 52 weeks, followed by a 20-week safety follow-up period. The study includes a total of 9 site visits and 20 phone or home visits during the participant's involvement. Participants will be involved in regular assessments including endoscopic nasal polyp scoring and nasal congestion symptom evaluations at baseline and throughout the 24 weeks, among other time points. Researchers will monitor changes in nasal polyp scores and nasal congestion scores to measure the treatment effects. Safety and tolerability will be closely followed during the treatment and safety follow-up periods, with total participation lasting up to 76 weeks for most participants, or 56 weeks for those transitioning to an extension study.

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 ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Age-related macular degeneration (AMD) is an eye condition that causes gradual vision loss by damaging the macula, the central part of the retina. This damage can progress to a form called geographic atrophy (GA), leading to further vision problems. This study focuses on adults in Japan aged 40 years and older who have geographic atrophy secondary to AMD. The main goal is to evaluate the safety and tolerance of a treatment called ASP3021. Participants will receive monthly injections of ASP3021 into the affected eye for 12 months. This injection, called an intravitreal injection, aims to assess how well patients tolerate the treatment and to monitor any safety concerns. The study will continue as a post-marketing phase 4 trial in Japan, following the prior approval of IZERVAY. During the year-long study, participants will visit the clinic multiple times for health checks, eye exams, and imaging tests to monitor their vision and eye health. Researchers will track adverse events related to treatment, including serious side effects, over the 12 months. The study collects data on visual acuity, eye imaging results, and overall safety to better understand the effects of ASP3021 in this patient population.

Researchers are evaluating the safety, tolerability, and appropriate dosing of a new drug called ASP2246 in adults who have difficulty moving several months after experiencing a stroke. This phase 1/2 study focuses on people who have motor problems related to late subacute to chronic ischemic stroke caused by supratentorial perforator area infarction. The study includes two parts to carefully assess the effects and risks of ASP2246. In Part 1, participants will undergo brain surgery during which varying doses of ASP2246 will be slowly delivered directly into the damaged brain area through a special tube. This dose escalation helps determine safe and tolerable levels. In Part 2, different groups will have the same surgery with either a higher or lower dose of ASP2246 based on Part 1 results, or a sham surgery where no drug is given, so neither participants nor most study doctors know who receives the drug. After surgery, participants will receive rehabilitation therapy three times a week for up to 12 weeks. Throughout the study, participants will be monitored for safety and any side effects up to one year after surgery. Assessments include tracking dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, special adverse events, and suicidal thoughts or behaviors. Physical therapy progress and safety checkups will be conducted regularly, with an observation period of about two weeks post-surgery and follow-up continuing for up to 52 weeks.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.

Researchers are evaluating how well vortioxetine tablets at doses of 10 mg/day or 20 mg/day work compared to placebo tablets for treating depression symptoms in Japanese teenagers aged 12 to 17 years who have been diagnosed with Major Depressive Disorder (MDD). This phase 3 clinical trial aims to assess the drug's effectiveness, safety, and how the body processes the medication in this pediatric population. Participants will be randomly assigned to receive either vortioxetine or a placebo once daily for 14 weeks. The study includes an initial screening period of up to 15 days to determine eligibility, followed by the 14-week treatment phase. After completing treatment, there is a 4-week period dedicated to monitoring any side effects. Throughout the study, participants will visit the clinic 13 times for assessments and medication administration. During the study, participants will undergo evaluations including the Children Depression Rating Scale Revised version (CDRS-R) to measure changes in depression symptoms from baseline to week 14. Other assessments include safety monitoring and pharmacokinetics. Researchers will also collect information on side effects during and after treatment. The total time commitment for participants is about 20 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the overall survival of males with chemotherapy-naefve metastatic castration-resistant prostate cancer (mCRPC). This phase 3 randomized study compares treatment with xaluritamig plus abiraterone to the investigator's choice of docetaxel, cabazitaxel, or abiraterone. Participants must have confirmed prostate adenocarcinoma with metastatic lesions and evidence of disease progression despite prior androgen receptor pathway inhibitor therapy. The study includes two treatment groups: one receiving intravenous xaluritamig combined with oral abiraterone acetate, and the other receiving the investigator's choice of chemotherapy drugs docetaxel or cabazitaxel administered intravenously, or abiraterone taken orally. Participants intended for cabazitaxel must have had up to six cycles of prior docetaxel in the metastatic hormone-sensitive setting. Treatments are administered per protocol during the randomized phase. Participants will be monitored for overall survival for up to approximately 51 months. Eligibility requires adequate organ function and good performance status. The study excludes those with prior chemotherapy in the mCRPC setting, certain prior therapies, unresolved toxicities, or CNS metastases. Researchers will assess survival outcomes along with safety and treatment tolerability throughout the study duration.