Anjo

Researchers are evaluating the effectiveness of axatilimab combined with corticosteroids compared to a placebo with corticosteroids as the initial treatment for moderate or severe chronic graft-versus-host disease cGVHD. This Phase 3 randomized, double-blind, placebo-controlled study aims to improve treatment outcomes for patients experiencing cGVHD after allogeneic hematopoietic cell transplantation allo-HCT. Participants will receive either axatilimab or a matching placebo, both administered by intravenous infusion, alongside corticosteroids given orally or by infusion at protocol-defined doses. The study randomly assigns participants to one of these two treatment groups to compare their effects as initial therapy for cGVHD. During the study, participants will be monitored over a period of up to three years to assess event-free survival and other outcomes such as response rates, corticosteroid dose reduction, survival, and safety. Researchers will collect data including laboratory tests, monocyte phenotype changes, and bone health markers. This comprehensive monitoring is designed to evaluate the benefits and risks of the treatments throughout and following the active treatment period.

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating the early use of empagliflozin, taken once daily by mouth, in patients hospitalized with acute heart failure who are at high risk of complications. This Phase 3, multicenter, randomized, double-blind trial compares empagliflozin to a placebo to assess its safety and effectiveness. The study is sponsored by Juntendo University and focuses on important outcomes like death, rehospitalization, worsening heart failure, and urine output within 90 days of treatment. Participants will be randomly assigned to receive either empagliflozin 10 mg once daily or a matching placebo. Treatment begins within 12 hours of hospital presentation. Both groups will be closely monitored during hospitalization and for up to 90 days after starting the study drug. The study uses a quadruple-blind design, meaning patients, caregivers, investigators, and assessors do not know which treatment is given. During the study, participants will undergo various assessments including monitoring of heart failure symptoms, urine output, blood tests for heart and kidney function, and quality of life questionnaires. Researchers will measure outcomes such as death rates, heart failure rehospitalizations, symptom changes, and kidney function over 90 days. Safety will be closely tracked throughout the study period. Total participation time varies but includes hospital stay and follow-up visits up to 90 days.

Researchers are evaluating the efficacy and safety of mocravimod as an additional and maintenance treatment in adults with acute myeloid leukemia AML undergoing allogeneic hematopoietic cell transplantation HCT. This phase III, multicenter, randomized, double-blinded, placebo-controlled trial focuses on AML patients receiving stem cell transplants to assess relapse-free survival and overall survival outcomes. Participants will be assigned to one of three groups receiving either 3 mg or 1 mg of mocravimod orally once daily for 12 months, or a matching placebo orally once daily for the same duration. The study drugs are taken continuously over the one-year treatment period following transplantation, with the goal to evaluate mocravimod as a supportive therapy alongside standard care. During the study, participants will be monitored with regular clinical assessments, including evaluation of relapse-free survival at 12 months and overall survival at 24 months. Safety and efficacy will be closely observed through follow-up visits. The total participation duration spans at least one year of treatment plus extended survival monitoring, ensuring comprehensive data collection on the impact of mocravimod in this patient population.

Multiple myeloma is a cancer affecting plasma cells in the bones and bone marrow, causing bone pain, fractures, infections, weak bones, and kidney failure. This study is evaluating the investigational drug etentamig compared to standard available therapies in adults with relapsed or refractory multiple myeloma. The study aims to understand changes in disease symptoms and treatment effects over time in this population. Participants are randomly assigned to one of two groups Arm A receives etentamig as an intravenous infusion given in 28-day cycles, and Arm B receives standard available therapies chosen by the investigator based on local guidelines. The study will last about 3.5 years, with treatments and monitoring continuing throughout this period. Participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure outcomes such as progression-free survival, response rates, overall survival, symptom changes, and quality of life using questionnaires and clinical tests. The study includes careful safety monitoring and may involve more treatment visits than standard care.