Dordrecht

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

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 the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a genetic condition causing fluid-filled cysts in the kidneys, leading to kidney disease. This Phase 2 study is investigating the safety and effectiveness of ABBV-CLS-628, an investigational drug, in adults with ADPKD. The study aims to evaluate how well ABBV-CLS-628 works and monitor any side effects in this population. Participants will be assigned to one of four groups, with each group receiving a different treatment. There is a 1 in 4 chance of receiving a placebo. Treatments, either ABBV-CLS-628 or placebo, will be given by intravenous infusion every 4 weeks for 92 weeks. After this treatment period, participants will be followed for up to an additional 15 weeks. During the study, participants will attend regular visits at hospitals or clinics where their health will be monitored through medical exams, blood tests, and questionnaires. Researchers will measure changes in total kidney volume over 96 weeks and track any adverse events up to approximately 118 weeks. The study involves around 240 adults aged 18 to 55 years with specific stages of ADPKD.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in adults with newly diagnosed multiple myeloma. This phase 3 study aims to determine which maintenance treatment better supports patients following their initial transplant and induction therapies. Participants must have responded to prior treatments and undergone ASCT within specified time frames. Participants will receive either iberdomide or lenalidomide at specified doses on scheduled days as maintenance therapy after their ASCT. The study is randomized, multi-center, and open-label, meaning both participants and researchers know which treatment is given. The treatments will be administered following a standard induction therapy including proteasome inhibitors, immunomodulatory drugs, and possibly monoclonal antibodies, with or without consolidation after transplant. Throughout the study, participants will be monitored for progression-free survival for up to 6 years to assess how well the maintenance therapies prevent disease progression. Researchers will also evaluate safety and treatment response according to established myeloma criteria. Regular assessments will include clinical evaluations and monitoring for any signs of disease relapse or adverse effects over the long term.

Researchers are investigating preventive treatments to reduce the occurrence, severity, and duration of taste changes (dysgeusia) related to talquetamab and ramantamig in patients with multiple myeloma. This Phase 2 open-label study aims to better understand the signs and symptoms of these oral events during a preventive treatment phase. Participants have multiple myeloma and have previously received specific prior therapies. The study involves several treatment options, including talquetamab and ramantamig, both given by subcutaneous injection, along with four different prophylaxis treatments (Prophylaxis A, B, C, and D) administered either orally or topically. These treatments are evaluated during the prophylaxis phase lasting up to 12 months. The goal is to assess how well these interventions prevent taste changes associated with talquetamab. Participants will be monitored for the presence and severity of taste changes through a standardized taste test called the Total Waterless Empirical Taste Test (WETT). Researchers will measure the percentage of participants experiencing dysgeusia, time to onset of severe taste changes, and the percentage reporting improvement or resolution at specific time points during the 12-month prophylaxis phase. Safety and adherence to lifestyle guidelines are also part of the participant evaluations throughout the study.

This research aims to evaluate the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi). The study is a Phase 3, open-label, randomized trial sponsored by BeOne Medicines. The goal is to better understand treatment options for patients whose disease has returned or did not respond to earlier therapies involving cBTKi. Participants will receive either BGB-16673 or pirtobrutinib, both given orally. The study compares these two treatments to assess their safety and efficacy. The treatment period and dosing details are managed as per the trial protocol to evaluate the outcomes of each drug. The study includes ongoing monitoring and assessments to observe treatment effects over time. During the study, participants will be closely followed for up to approximately 3 years to measure progression-free survival, as assessed by an independent review committee. Researchers will conduct regular evaluations including imaging and laboratory tests to track disease status and safety. Participants' health will be monitored throughout the study to identify any side effects or changes in condition.