Isehara

This research aims to evaluate the long-term safety and effectiveness of pirtobrutinib in patients with Chronic Lymphocytic Leukemia or Non-Hodgkin Lymphoma. It uses a master protocol design that includes participants from previous clinical studies (called originator studies) of pirtobrutinib. These participants can continue treatment or follow-up as part of this ongoing evaluation. Participants receive pirtobrutinib orally, continuing from their prior originator studies. The master protocol oversees individual study-specific appendices (ISAs) that include these participants, allowing for a structured and continuous assessment of the treatment's long-term use. During the study, researchers monitor the occurrence of significant treatment-related adverse events from the first dose until 30 days after the last dose or the start of a new anticancer therapy. This includes tracking and evaluating safety outcomes to better understand the long-term effects of pirtobrutinib in these patient populations.

Researchers are investigating the safety, tolerability, and effectiveness of two dosing regimens of itepekimab compared to placebo as an add-on to intranasal corticosteroids in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) that is not well controlled. This multinational Phase 3, randomized, double-blind, placebo-controlled trial involves male and female participants aged 18 years and older living with CRSwNP. Participants are randomly assigned to one of three groups receiving either itepekimab injections or placebo injections, both administered subcutaneously, alongside mometasone furoate nasal spray delivered intranasally. The study includes a 4-week screening period, followed by a 52-week treatment phase, and a 20-week safety follow-up, totaling up to 76 weeks. Participants transitioning to an extension study (LTS18420) will have a total duration of 56 weeks. Study visits include nine site visits and 20 phone or home visits. During the trial, participants will undergo assessments including endoscopic Nasal Polyp Scores (NPS) and Nasal Congestion Scores (NCS) measured from baseline to week 24 to evaluate changes. Researchers will monitor safety and tolerability throughout, with regular evaluations involving symptom severity, treatment adherence, and adverse events. The study aims to understand how well itepekimab works and is tolerated as an additional treatment for CRSwNP over the study duration.

Researchers are evaluating the effectiveness and safety of CLS2901C, a human allogenic chondrocyte sheet product, in patients with osteoarthritis of the knee. This phase III study compares outcomes between patients receiving CLS2901C combined with osteotomy plus RMSC and those undergoing osteotomy alone. The study involves patients diagnosed with knee osteoarthritis classified as Kellgren-Lawrence Grade 2 to 4. The investigational treatment, CLS2901C, is made by culturing chondrocytes obtained from cartilage tissue of patients with polydactyly. Patients will be assigned to either receive osteotomy surgery alone or osteotomy plus transplantation of CLS2901C sheets. The evaluation period for each group lasts approximately 14.5 months, including a 52-week assessment phase. After this, participants who continue follow-up will be observed for an additional five years to monitor long-term effects after sheet transplantation. Participants will undergo assessments including the Knee injury and Osteoarthritis Outcome 4 (KOOS 4) score measured at 52 weeks to evaluate efficacy. Researchers will monitor safety through rates of adverse events and device malfunctions. Regular evaluations include imaging and clinical examinations to track cartilage condition and knee function throughout the study and extended follow-up period.

Study J2N-MC-JZ01 evaluates the long-term safety and efficacy of the drug pirtobrutinib in participants who have previously been treated for Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma. This study serves as an extension for participants from the completed originator study LOXO-BTK-18001, allowing them to continue their assigned treatment or follow-up visits. It is a Phase 4 study focused on monitoring ongoing outcomes after initial treatment phases. Participants receive pirtobrutinib orally as part of the study intervention. The study allows participants to transition seamlessly from the originator study to continue either treatment or follow-up. This design supports long-term observation of the drug's effects beyond the initial trial period. During the study, researchers will monitor participants for treatment-emergent adverse events of Grade 3 or higher, tracking safety from the first dose through 30 days after the last dose or until a new anticancer therapy begins. The total duration depends on each participant's treatment and follow-up schedule. Regular assessments will help evaluate the drug's safety profile and ongoing efficacy.

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 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.

This research aims to evaluate the safety and effectiveness of iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a topoisomerase inhibitor, compared to the treatment of physician's choice (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, or capecitabine). The study focuses on patients with previously untreated, locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, HER2-negative breast cancer who are not eligible for anti-PD(L)1 or endocrine therapies. The trial is conducted in two phases, phase 2 and phase 3, to thoroughly assess these treatments.

Researchers are evaluating how well nipocalimab works compared to a placebo in adults with moderate to severe systemic lupus erythematosus (SLE), a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study focused on adults aged 18 to 75 who have active SLE symptoms and have been diagnosed for at least 24 weeks. Participants will receive either nipocalimab or a placebo alongside standard of care treatments, which include protocol-defined topical and systemic therapies. Nipocalimab and placebo are administered as drugs while maintaining background treatments. The study monitors participants over time, including a primary outcome measurement at Week 52 to assess the percentage of participants achieving a systemic lupus erythematosus responder index (SRI)-4 composite response. During the study, participants will be regularly assessed for disease activity, vital signs, and safety. Screening includes physical examinations, medical history review, vital signs, and electrocardiograms. Researchers will monitor disease activity scores and evaluate response to the treatment at Week 52. Safety is closely observed throughout the study, with particular attention to any adverse reactions or changes in health status. The total participation and follow-up extend at least through Week 52.

This research aims to evaluate the long-term safety of pirtobrutinib in adults who have previously been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It focuses on participants who completed a prior study (J2N-MC-JZNN/LOXO-BTK-20020) and offers them continued access to the study drug or follow-up visits. The study is in Phase 4 and targets assessing safety outcomes over an extended period. Participants will receive pirtobrutinib orally every four weeks. The study includes treatment administration and ongoing follow-up for about five years, allowing researchers to monitor the long-term effects of the drug. Idelalisib is also listed as an intervention but the study primarily assesses pirtobrutinib. Throughout the study, researchers will monitor participants for any treatment-emergent adverse events of grade 3 or higher from the first dose until 30 days after the last dose or start of new anticancer therapy, whichever occurs first. Participants will be regularly assessed during their visits to ensure safety and collect necessary data over the duration of the study.

Researchers are evaluating sacituzumab tirumotecan alone and combined with pembrolizumab compared to the treatment chosen by a physician for people with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on participants whose cancer has progressed despite prior endocrine therapy, including treatment with a CDK4/6 inhibitor. The main goal is to see if these treatments improve progression-free survival, which means the length of time the cancer does not worsen, over up to approximately 38 months. Participants receive sacituzumab tirumotecan as an intravenous infusion, either alone or combined with intravenous pembrolizumab. The comparison group receives the treatment of physician's choice, which may include intravenous paclitaxel, nab-paclitaxel, liposomal doxorubicin, or oral capecitabine. The study is open-label and randomized, meaning participants are assigned to different treatment groups openly. Treatments are administered according to the study protocols, with ongoing monitoring during the treatment period. Throughout the study, participants are monitored regularly to assess their cancer status and overall health. This includes evaluations by blinded independent central review using RECIST 1.1 criteria to measure tumor progression. Researchers also assess safety, organ function, and performance status. The total participation time may last up to around 38 months to track progression-free survival and other outcomes. Careful monitoring helps ensure participant safety and collects data on treatment effectiveness and side effects.