Tsukuba

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

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 the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are studying an experimental combination of two drugs called pozelimab and cemdisiran for adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. The study aims to evaluate the long-term safety and effectiveness of this drug combination. It also investigates how the drugs behave in the body, possible side effects, and whether the body might develop antibodies against them that could affect treatment. Participants in this Phase 3 open-label extension study receive pozelimab and cemdisiran according to the study protocol. The study includes people who completed a parent study or those with a specific genetic variation (C5 polymorphism) making them resistant to certain other treatments. Treatments are administered as directed, and meningococcal vaccinations are required as part of the protocol. During the study, participants will attend clinic visits for various assessments, including safety monitoring for serious and special side effects up to week 108, and blood tests to measure changes in lactate dehydrogenase (LDH) levels up to week 36. Researchers will track adverse events, treatment tolerance, and collect data on drug levels and antibody formation. The total study duration covers long-term follow-up to better understand the treatment's effects and safety.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.

Researchers are evaluating the safety and effectiveness of brenipatide compared to a placebo for adults with moderate-to-severe Alcohol Use Disorder (AUD). This phase 3 study aims to better understand if brenipatide can help reduce drinking in this population. Participants will be followed for about 56 weeks to gather comprehensive information. Participants will receive either brenipatide (LY3537031) or a placebo, both given by subcutaneous injection. The study involves a randomized, double-blind design, meaning neither the participants nor the researchers know who receives which treatment during the trial. This method helps provide reliable results about the effects and safety of brenipatide. During the study, participants will attend scheduled visits, self-inject the study drug, and complete electronic and paper diaries as well as questionnaires. Researchers will monitor changes in drinking patterns using the Timeline Followback Method for up to 56 weeks. Safety monitoring and regular assessments will be performed throughout the study to track participants' health and adherence.

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.

This research aims to evaluate the antiviral effects of S-337395 compared with placebo in nonhospitalized adult participants who have symptomatic respiratory syncytial virus (RSV) infection and are at high risk of progressing to severe disease. The study focuses on adults with recent onset of RSV symptoms and important risk factors such as advanced age or chronic lung or cardiovascular disease. It is designed as a Phase 2b, randomized, double-blind, placebo-controlled trial to assess safety, tolerability, and efficacy. Participants will receive either S-337395 or a matching placebo according to a specified dosing schedule. The treatment begins within 72 hours of RSV symptom onset. The study measures changes in RSV viral RNA load from baseline to Days 2, 4, and 6 using nasopharyngeal swabs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) tests to monitor antiviral effects. During the study, participants will be monitored for safety and effectiveness through viral load testing at multiple time points. Medical history, physical exams, vital signs, and ECGs are conducted to ensure stability aside from RSV symptoms. The study also tracks symptoms and any adverse events to evaluate treatment tolerability. Total participation includes screening and follow-up assessments as outlined by the study protocol.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.