Urayasu

Researchers are evaluating the safety and effectiveness of GIA632 in adults aged 18 to 99 years with non-segmental vitiligo NSV. This randomized, double-blind, placebo-controlled Phase 2b study aims to understand the dose-response relationship of GIA632 and determine the best dose to advance to a Phase 3 study. Participants have NSV affecting specific body surface areas confirmed by physical examination. Participants are randomly assigned to receive one of four different doses of GIA632 or a placebo. The assigned treatment is administered over a 48-week core period. After this period, an extension phase assesses longer-term safety and efficacy of the study drug. The study compares changes in facial and total body vitiligo scores at various time points up to 48 weeks. Throughout the study, participants undergo assessments including Vitiligo Area Scoring Index VASI measurements on the face and body, and the Vitiligo Noticeability Scale VNS. These assessments occur at baseline and multiple follow-up visits up to week 48. Researchers monitor participants for treatment effects and safety during the entire study duration, which runs until 2030, ensuring detailed evaluation of GIA632 over time.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are studying primary membranous nephropathy PMN, a kidney condition where harmful autoantibodies build up in the kidney filters, causing damage. This can lead to protein and blood leaking into the urine, swelling, tiredness, and high blood pressure. The study aims to compare how the laboratory-made antibody drug felzartamab works compared to the existing drug tacrolimus in treating PMN, focusing on how many participants achieve complete remission over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus as oral tablets. Those whose disease worsens or who do not improve may receive additional rescue treatment, including standard immunosuppressive therapy or felzartamab. The study includes an open-label treatment phase and a non-responder treatment phase for those needing rescue therapy. Participants will undergo up to 23 study visits during screening and treatment, which may last up to 104 weeks or 156 weeks if rescue treatment is needed. Researchers will monitor urine protein levels, kidney function, antibody levels, physical health, and side effects. Follow-up visits every 12 weeks will continue if treatment stops early to assess long-term effects and safety.

Researchers are evaluating the effects of a medicine called BI 1815368 in adults aged 18 and older who have a specific eye condition known as centre-involved diabetic macular edema CI-DME. This condition affects vision, and the study aims to find out if BI 1815368 can improve sight and to determine the best dose. The trial is a phase 2, randomized, double-masked, placebo-controlled study designed to assess efficacy, safety, and tolerability. The study has two parts. In the first part, participants are randomly assigned to one of two groups one receiving BI 1815368 tablets and the other receiving placebo tablets that look identical but contain no medicine. In the second part, participants are randomly assigned to one of four groups three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take the tablets twice daily for about 11 months. Participants stay in the study for about one year, during which they visit the study site 16 times. At these visits, doctors check vision, document any health problems, and take detailed eye pictures. Researchers compare changes over time between the groups to evaluate if the treatment affects vision. The main outcome measured is whether participants gain at least 10 Early Treatment Diabetic Retinopathy Study ETDRS letters in vision at Week 48 compared to baseline.

Researchers are evaluating the medicine BI 3000202 for adults with systemic lupus erythematosus SLE, a condition involving immune system problems. The study is a phase 2 trial that tests different doses of BI 3000202 to find the best dose for people with moderate to severe SLE. Participants are randomly assigned to one of five groups, including four groups receiving different doses of the medicine and one group receiving a placebo, which looks like the medicine but has no active drug. Participants take their assigned tablets daily for one year while continuing their usual SLE treatments. The study groups include four different dose levels of BI 3000202 and a placebo group. During the study, participants regularly visit the study site for check-ups and monitoring. This careful schedule helps researchers watch for any effects or side effects of the treatment. Throughout the study, doctors assess participants health, monitor any unwanted effects, and compare outcomes between groups. The main measurement is whether participants achieve a response on the Systemic Lupus Erythematosus Responder Index SRI-4 at week 32. Additional measurements include responses at week 52 and disease activity scores. Participants stay involved for a bit longer than one year, with regular visits to the study site for health checks and to ensure their well-being.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

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.