Nizip

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 the effectiveness and safety of luspatercept combined with best supportive care compared to placebo plus best supportive care in treating anemia in adult participants diagnosed with alpha-thalassemia hemoglobin H (HbH) disease. The study also aims to assess the safety and measure drug levels of luspatercept in adolescent participants with the same condition. This is a Phase 2 study focusing on participants aged 12 years and older, including both adolescents and adults with varying transfusion dependence. Participants will receive either luspatercept or a placebo at specified doses on scheduled days while continuing best supportive care. The study includes both transfusion-dependent and non-transfusion-dependent participants, with specific definitions for each group based on recent red blood cell transfusion history and hemoglobin levels. The study measures include up to 48 weeks for evaluating reductions in transfusion burden and up to 102 weeks for pharmacokinetics, with safety monitored throughout. During the study, participants will have regular assessments measuring transfusion needs, hemoglobin levels, and any adverse events, including dose-limiting toxicities within the first three weeks. Blood samples will be collected to monitor drug levels and overall safety over a long-term period of up to 8.5 years. Researchers will track changes in hemoglobin, transfusion frequency, side effects, and medication concentration to determine the treatment's impact and safety profile.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and immunogenicity of benralizumab in children with rare eosinophilic diseases. This open-label, multicenter basket study includes pediatric participants with eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES), with plans to add other eosinophilic disease cohorts in future amendments. The trial is a phase 3 study designed to understand the effects of repeat dosing of benralizumab on these conditions. Participants will receive benralizumab as a subcutaneous injection every 4 weeks during a 52-week open-label treatment period. Those who complete this period may continue receiving benralizumab in an extension phase lasting at least an additional 52 weeks, followed by a safety follow-up period after the last dose. The dosing schedule and treatment duration are consistent for all eligible participants throughout the study. During the study, participants will be monitored for adverse events from screening through week 52, and serum benralizumab concentrations will be measured at weeks 0, 12, 24, 25, 36, and 52. The study involves a screening period of 1 to 4 weeks before treatment starts, followed by the treatment and extension phases. Researchers will assess safety, drug levels, and treatment effectiveness while tracking participants' response and tolerability over time.

Researchers are evaluating the effectiveness of brenetafusp (IMC-F106C) combined with nivolumab compared to standard nivolumab treatments in people who have advanced melanoma that has not been treated before. This study focuses on participants who have a specific genetic marker called HLA-A*02:01 and aims to understand how these treatments affect the progression of their cancer. The study is a phase 3, randomized, controlled trial, which helps ensure reliable comparison between the different treatment regimens. Participants in this study will receive either brenetafusp plus nivolumab or standard nivolumab regimens, which may include nivolumab alone or in combination with relatlimab. These treatments are given by intravenous infusion, with specific dosing of the drugs as concentrates for infusion. The study compares these approaches to see which is more effective in controlling the melanoma. During the study, participants will be closely monitored for disease progression and overall health. Researchers will use scans and other assessments to measure progression-free survival, which is the time participants live without their disease worsening, followed for up to about 45 months. Safety and response to treatment will be regularly evaluated to better understand the effects of the therapies over time.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating the safety and effectiveness of combining trastuzumab deruxtecan (T-DXd) with rilvegostomig compared to standard treatments in patients with advanced HER2-expressing biliary tract cancer who have not received prior therapy. This phase 3 study focuses on patients with locally advanced or metastatic disease and aims to measure overall survival and safety outcomes. Participants will receive one of the following treatments: the experimental combination of T-DXd and rilvegostomig by intravenous infusion, T-DXd alone, or a standard care regimen consisting of gemcitabine, cisplatin, and durvalumab given intravenously. The study includes a safety run-in period to assess tolerability of the combination, followed by a randomized phase where patients receive assigned treatments. Each treatment cycle lasts 21 days. During the study, participants will be closely monitored through clinical assessments, laboratory tests, and imaging to evaluate tumor response and safety. Researchers will track overall survival from the time of treatment initiation until death from any cause, with follow-up estimated up to 50 months. Additional assessments include performance status, organ function, and tumor tissue analysis to confirm HER2 expression and other markers. Safety and side effects will be continuously evaluated throughout the study.

Researchers are evaluating the effectiveness and safety of rilvegostomig combined with bevacizumab, with or without tremelimumab, compared to atezolizumab combined with bevacizumab in people with advanced hepatocellular carcinoma (HCC) who cannot undergo curative or localized treatments. This Phase III global study includes a safety lead-in period to assess the tolerability of rilvegostomig with bevacizumab and tremelimumab before the randomized treatment phase begins. Participants receive intravenous treatments with rilvegostomig, bevacizumab, and tremelimumab in one group, while another group receives atezolizumab with bevacizumab. The study has two parts: a safety lead-in where all participants get rilvegostomig, bevacizumab, and tremelimumab to check safety, followed by a randomized period comparing the three treatment arms. The treatments are given as first-line therapy for advanced HCC. During the study, participants are regularly monitored through imaging and lab tests to measure tumor response and organ function. Researchers track overall survival up to about six years to evaluate treatment effectiveness. Safety and tolerability are closely observed throughout, with ongoing assessments to ensure participant well-being during treatment and follow-up periods.

Researchers are evaluating the safety and tolerability of tarperprumig in adults who have been newly diagnosed with or have relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. This Phase 2 study focuses on participants with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) subtypes, classified according to the 2022 ACR/EULAR criteria, who are considered for treatment with rituximab or cyclophosphamide. Participants must have a positive test for PR3-ANCA or MPO-ANCA antibodies and meet specific disease activity criteria based on the Birmingham Vasculitis Activity Score (BVAS). Participants will be randomly assigned to receive either tarperprumig or a placebo in a double-blind, placebo-controlled, parallel-group setup across multiple centers. The study evaluates the investigational drug tarperprumig against placebo to assess safety and efficacy in the target patient population. Treatment details and dosing schedules are not provided in the available information. Throughout the study, researchers will monitor the number of participants experiencing treatment-emergent adverse events from baseline to week 70. Safety and tolerability will be closely assessed during this period. Participants' health status and response to treatment will be regularly evaluated to determine the treatment effects and monitor any risks associated with tarperprumig.