Ota City

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are evaluating the effects of E6742, an oral tablet medication, compared to a placebo in adults with systemic lupus erythematosus (SLE). The main goal is to see how well participants respond to treatment based on a specific lupus assessment called the British Isles Lupus Assessment Group (BILAG) based Composite Lupus Assessment (BICLA), focusing on those who maintain a low dose of oral corticosteroids by Week 24. This is a Phase 2, randomized, double-blind, placebo-controlled study aimed at finding the best dose response of E6742 for treating SLE. Participants will receive either E6742 oral tablets or placebo tablets during the study. The study evaluates different doses to understand the medication's effects and safety. Before treatment, participants must have active lupus with specific disease activity scores and stable doses of certain lupus medications. The study includes a planned treatment period lasting at least 24 weeks, during which the response to therapy and safety are closely monitored. Throughout the study, participants will undergo regular assessments to measure lupus disease activity using BILAG and other scoring systems. Researchers will monitor medication adherence, side effects, laboratory tests, and physical exams to evaluate safety and effectiveness. The primary outcome is the percentage of participants achieving a BICLA response while on a low dose of corticosteroids at Week 24. The study also includes ongoing safety monitoring to ensure participant well-being during and after treatment.

Researchers are evaluating the effectiveness of Saruparib (AZD5305) compared to placebo when added to a standard radiation therapy (RT) and androgen deprivation therapy (ADT) regimen in men with high-risk and very high-risk localized or locally advanced prostate cancer who have a BRCA gene mutation. This phase III study aims to assess whether Saruparib can improve metastasis-free survival in this population. About 700 adult male participants will be randomly assigned to receive either Saruparib or placebo along with ADT. There are two groups: Cohort A includes 400 participants with newly diagnosed high-risk or very high-risk prostate cancer treated with primary RT or with high-risk biochemical recurrence after radical prostatectomy receiving salvage RT. Cohort B includes 300 participants with very high-risk locally advanced prostate cancer receiving primary RT combined with ADT and abiraterone. Saruparib and placebo will be given orally, and standard ADT and abiraterone with prednisone/prednisolone will be administered as per the regimen. Participants will be followed for up to about 93 months to monitor metastasis-free survival and overall safety. Assessments include imaging scans like CT, MRI, bone scans, and PSMA-PET to confirm disease status. The study also monitors organ function, performance status, and treatment adherence. An independent committee will review safety and efficacy data throughout the trial to ensure participant well-being and study integrity.

Researchers are evaluating the effectiveness of nipocalimab compared to a placebo in reducing the risk of fetal anemia in pregnant participants at risk for severe Hemolytic Disease of the Fetus and Newborn (HDFN). This Phase 3 study focuses on pregnancies with a history of severe HDFN and aims to improve outcomes for live neonates by addressing complications related to red blood cell volume during fetal development. Participants will receive either nipocalimab or a placebo through intravenous infusions. The study monitors the effects of these treatments on reducing fetal anemia and related severe outcomes such as fetal loss, intrauterine transfusion, hydrops fetalis, or neonatal death. Treatment is given during pregnancy, with careful tracking of maternal and fetal health. During the study, participants will undergo lab tests, physical exams, and monitoring of vital signs and heart activity. Researchers will assess the percentage of pregnancies that avoid adverse outcomes from randomization through the neonatal period, up to 4 weeks of age or 41 weeks postmenstrual age. Safety and efficacy will be closely observed throughout the study period.

Researchers are studying how well and safely orforglipron works in adult women who have stress urinary incontinence (SUI) and are overweight or have obesity. SUI is a condition where urine leaks during movements like coughing or exercising. This trial is part of a master protocol including two independent studies, and it is a Phase 3 clinical trial. Participants will be randomly assigned to receive either orforglipron tablets or a placebo, both taken orally once daily. The treatment period and study participation will last approximately 58 weeks, including screening and safety follow-up. The study compares the effects of orforglipron against placebo in this specific group of female patients. During the study, researchers will track changes in the frequency of incontinence episodes from the start to week 52. Participants will undergo screening, treatment, and safety monitoring throughout the trial. The study aims to assess the effectiveness and safety of orforglipron in reducing urinary leakage events over time.

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in reducing seated blood pressure and normalizing the Renin Angiotensin Aldosterone System (RAAS) in adults aged 18 years and older diagnosed with Primary Aldosteronism (PA). This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to include about 180 participants, some of whom may have prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Participants will be randomly assigned to receive either baxdrostat tablets or matching placebo tablets once daily. The dose may be increased after two weeks depending on clinical response and tolerability. The study is conducted in approximately 90 centers across 12 countries, providing a broad and diverse participant base. During the study, researchers will closely monitor seated systolic blood pressure and RAAS normalization at week 8 to assess the treatment effects. Participants will also undergo laboratory tests including serum potassium and sodium levels, kidney function evaluation, and blood pressure measurements. Safety and tolerability will be assessed throughout the study period, ensuring comprehensive monitoring of participants' health and response to treatment.

Researchers are evaluating the effectiveness of TAR-210 compared to a single-agent intravesical chemotherapy in adults with intermediate-risk non-muscle invasive bladder cancer (NMIBC) who have specific fibroblast growth factor receptor (FGFR) mutations or fusions. This phase 3 randomized study aims to compare disease-free survival between these treatments. Eligible participants must have a confirmed diagnosis of intermediate-risk NMIBC with certain risk factors and be willing to undergo multiple cystoscopies and assessments throughout the study. Participants will receive either TAR-210, which is delivered directly into the bladder, or one of the investigator-chosen intravesical chemotherapy drugs, including Gemcitabine or MMC, also administered into the bladder. Prior to randomization, visible tumors must be fully removed, and the absence of disease confirmed. The study includes a main study group and a substudy group with slightly different eligibility criteria based on tumor grade and risk factors. During the study, participants will be closely monitored through cystoscopies and surgical assessments (TURBT) to evaluate cancer recurrence or progression. The primary outcome measure is disease-free survival, tracked from randomization until the first documented cancer recurrence, progression, or death, over approximately four years and two months. Safety and treatment adherence will also be assessed throughout the study period.

Researchers are evaluating the effectiveness and safety of KarXT for treating schizophrenia in adolescents aged 13 to 17 years. This Phase 3 study focuses on adolescents who meet diagnostic criteria for schizophrenia and experience symptoms of psychosis. The study aims to better understand how KarXT may impact symptoms as measured by a standard schizophrenia rating scale. Participants will receive either KarXT or a matching placebo at specified doses on specific days. The study is randomized, double-blind, and placebo-controlled, meaning neither the participants nor the researchers know who receives the active drug or placebo during the trial. During the study, researchers will assess changes in schizophrenia symptoms using the Positive and Negative Syndrome Scale (PANSS) after 5 weeks of treatment. Participants will be monitored for safety and symptom changes throughout the study period. The goal is to gather detailed information about KarXT's impact on schizophrenia symptoms in this adolescent population.

Researchers are evaluating the effectiveness and safety of KarXT in Japanese adults aged 18 to 65 who are experiencing acute psychotic episodes due to schizophrenia. The study focuses on adults diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) and confirmed by a psychiatric interview. Participants must have a specific range of symptom severity measured by the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scale. Participants are randomly assigned to receive either KarXT or a placebo during a 5-week double-blind phase where neither the participants nor the researchers know which treatment is given. After this, there is a 52-week open-label extension where all participants receive KarXT. The doses are specified and administered on set days throughout the study. Throughout the study, researchers monitor changes in schizophrenia symptoms using the PANSS score at week 5 and track any treatment-emergent adverse events up to week 52 during the open-label extension. The study involves regular assessments to ensure safety and effectiveness over both the short and long term, with total participation lasting up to 57 weeks.