Uruma

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.

Researchers are evaluating treatments for participants with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. This Phase 3 study compares if the combination of belantamab mafodotin, lenalidomide, and dexamethasone (BRd) can extend progression-free survival or increase the number of participants achieving minimal residual disease negative status compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd). Participants will receive either BRd or DRd treatment. Belantamab mafodotin, lenalidomide, and dexamethasone will be administered in the BRd group, while daratumumab, lenalidomide, and dexamethasone will be given in the DRd group. The study will monitor participants over approximately 7 years to assess long-term outcomes. During the study, participants will undergo assessments to measure progression-free survival and minimal residual disease status. Researchers will collect clinical data, laboratory tests, and safety information throughout the treatment and follow-up periods. The total duration of participation may last up to about 7 years to evaluate long-term effects and outcomes of the treatments.

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 the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

Researchers are evaluating the effectiveness, safety, and behavior of a new treatment called sefaxersen (RO7434656), an Antisense Oligonucleotide (ASO) therapy, for people with primary IgA nephropathy (IgAN). The study focuses on participants who have a high risk of their kidney disease worsening despite receiving the best available supportive care. This is a Phase III, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants will receive either sefaxersen or a matching placebo through subcutaneous injections according to a specified schedule. The study compares these two groups to see how the treatment affects kidney function over time. The intervention is designed to inhibit Complement Factor B, which is involved in the disease process. The study includes vaccination requirements and contraceptive use for women of childbearing potential to ensure safety. During the study, participants will be monitored for changes in their urine protein-to-creatinine ratio (UPCR) at baseline and at week 37, which is the primary measure of kidney function improvement. Other assessments include kidney biopsy results, kidney function tests estimating glomerular filtration rate (eGFR), and ongoing safety evaluations. The trial tracks participants' health closely to assess the treatment's effect and any side effects throughout the study period.

Researchers are evaluating the safety and effectiveness of lutetium (177Lu) vipivotide tetraxetan (AAA617) in adult men with oligometastatic prostate cancer (OMPC) that is progressing after initial treatment to the primary tumor. This Phase III study aims to determine if AAA617 can control recurrent tumors and delay the need for androgen deprivation therapy (ADT), while preserving quality of life. The study focuses on early-stage prostate cancer patients with limited metastatic lesions that are positive for prostate-specific membrane antigen (PSMA). All participants will undergo a baseline PET/CT scan using either gallium (68Ga) gozetotide or piflufolastat (18F) to confirm PSMA-positive lesions, along with conventional imaging such as CT/MRI and bone scans. Following randomization, all metastatic lesions will receive stereotactic body radiation therapy (SBRT) over approximately 3 weeks. Participants randomized to the investigational arm will then receive up to 4 cycles of AAA617 treatment, given once every 6 weeks. Those in the observation group will end treatment after SBRT. Visits are scheduled weekly during treatment cycles and every 16 weeks afterward until disease progression, with the overall study lasting about 6.5 years. During the study, participants will have regular assessments including imaging scans, laboratory tests, and clinical evaluations to monitor disease progression and side effects. A blinded independent review committee will measure metastasis-free survival, tracking time from randomization until evidence of distant metastasis or death, for up to 30 months. Safety and quality of life will also be closely monitored throughout the study and follow-up periods.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating a new treatment approach for patients newly diagnosed with Glioblastoma (GBM), a type of brain tumor. This phase 3, randomized, double-blind study compares the combination of the Optune4 device delivering Tumor Treating Fields (TTFields) at 200 kHz, maintenance Temozolomide (TMZ) chemotherapy, and pembrolizumab against Optune4 with maintenance TMZ and a placebo. The main goal is to assess overall survival over 24 months in these patients. Participants will receive the Optune4 device continuously alongside maintenance TMZ chemotherapy dosed at 150-200 mg/m2 daily for 5 days every 28 days. One group will also receive pembrolizumab given intravenously at 200 mg every 3 weeks for up to 35 cycles, while the other group will receive a placebo infusion on the same schedule. Prior to study treatment, patients must have completed standard chemoradiotherapy and recovered from surgery without Gliadel wafers placement. During the study, participants will be closely monitored for survival and treatment safety. Researchers will assess overall survival at 24 months and track treatment effects through scheduled evaluations. Participants need to have good performance status and stable corticosteroid use before randomization. The study aims to provide important data on combining Optune4, TMZ, and pembrolizumab in newly diagnosed GBM patients over the course of treatment and follow-up.

Researchers are evaluating the safety and effectiveness of peficitinib in patients with rheumatoid arthritis (RA) receiving treatment in routine clinical practice. This mandatory Post-Marketing Surveillance (PMS) study is conducted as part of the Japan Risk Management Plan (J-RMP) and requested by the Pharmaceuticals and Medical Devices Agency (PMDA). The aim is to collect real-world data on patients treated with peficitinib for RA. The study involves treatment with oral peficitinib, given as part of routine clinical care. There are no comparator groups; all participants will be patients receiving peficitinib for the first time. The study focuses on monitoring safety and effectiveness in an actual clinical setting without altering the standard treatment schedule. Participants will be followed for up to 156 weeks to assess safety outcomes such as the frequency of adverse events, serious infections, malignancies, and events leading to death. Effectiveness will be measured up to 52 weeks using disease activity scores including DAS28 (using C-reactive protein and erythrocyte sedimentation rate), Simplified Disease Activity Index, Clinical Disease Activity Index, tender and swollen joint counts, and global assessments by patients and physicians. Researchers will also evaluate EULAR response criteria and remission rates. This long-term follow-up provides comprehensive safety and effectiveness data in real-world RA treatment.