Nizip

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the efficacy and safety of luspatercept combined with best supportive care compared to placebo with best supportive care in adults with alpha-thalassemia hemoglobin H disease who experience anemia. The study also assesses the safety and drug levels of luspatercept in adolescents with this condition. This phase 2 trial aims to understand how luspatercept affects anemia and transfusion needs in this population. Participants are randomly assigned to one of four groups based on their transfusion dependence status adults who receive luspatercept plus best supportive care, adults who receive placebo plus best supportive care, adolescents who are transfusion dependent receiving luspatercept plus best supportive care, or adolescents who are non-transfusion dependent receiving luspatercept plus best supportive care. The treatments are given on specified days, and participants are monitored for up to 108 weeks, including assessments of drug levels, transfusion burden, hemoglobin changes, and adverse events. Throughout the study, participants undergo regular evaluations including blood tests to measure hemoglobin and transfusion needs, monitoring for side effects, and quality of life assessments. Researchers also track long-term safety outcomes and pharmacokinetics of the drug. The main outcomes include reductions in red blood cell transfusions over 12 to 48 weeks and increases in hemoglobin levels without transfusions. Participants may be followed for up to five years to monitor safety and treatment effects.

Researchers are evaluating benralizumab in children aged 6 to under 18 years with rare eosinophilic diseases, including eosinophilic granulomatosis with polyangiitis EGPA and hypereosinophilic syndrome HES. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy, and immunogenicity of repeated dosing of benralizumab given every 4 weeks. This open-label, multicenter Phase 3 trial enrolls pediatric participants and may add additional cohorts for other eosinophilic diseases in the future. Participants will receive benralizumab as a subcutaneous injection every 4 weeks during a 52-week open-label treatment period. Dosing depends on weight those weighing 35 kg or more receive one dose level, and those under 35 kg receive a different dose. Participants who complete the initial 52 weeks may continue into an extension period to receive at least an additional year of benralizumab treatment. The study includes three periods screening 1 to 4 weeks, treatment 52 weeks, and an open-label extension period at least 52 weeks plus safety follow-up. During the study, participants will be monitored regularly for adverse events and blood levels of benralizumab at specific weeks. Additional assessments include evaluating disease remission, eosinophil counts, antidrug antibodies, and flare-ups or relapses related to EGPA or HES. Patient-reported outcomes like the Patient Global Impression of Change are also collected. Safety follow-up occurs after the last dose, with study participation lasting multiple years depending on extension enrollment.

Researchers are evaluating the combination of brenetafusp IMC-F106C plus nivolumab compared to standard nivolumab regimens in people with previously untreated advanced melanoma who are HLA-A*0201-positive. This phase 3, randomized, controlled study aims to understand how these treatments perform in this specific group. The study focuses on improving progression-free survival and overall outcomes for participants with advanced melanoma. Participants are assigned to one of three groups one group receives a low dose of brenetafusp once weekly for 13 weeks, then every two weeks until Week 51, and every four weeks thereafter, along with nivolumab every four weeks another group receives a high dose of brenetafusp on the same schedule plus nivolumab the third group receives nivolumab alone or nivolumab combined with relatlimab every four weeks. The study includes a dose recommendation phase with changes made in November 2025 based on safety and efficacy data. During the study, participants undergo assessments including tumor measurements per RECIST 1.1, BRAF V600 mutation status evaluation, and performance status scoring. Researchers will monitor progression-free survival up to approximately 45 months, overall survival up to 57 months, and record adverse events, immune responses, and quality of life. The study involves regular dosing and long-term follow-up to evaluate treatment effects and safety.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

This research is investigating the safety and effectiveness of combining Trastuzumab deruxtecan T-DXd with rilvegostomig, compared to T-DXd alone or the standard chemotherapy regimen of gemcitabine plus cisplatin with durvalumab in patients who have advanced HER2-expressing biliary tract cancer and have not received prior treatment. The study focuses on patients with unresectable, locally advanced, or metastatic biliary tract adenocarcinoma that expresses HER2 protein. Participants are randomly assigned to one of three groups one receiving T-DXd combined with rilvegostomig, another receiving T-DXd alone, and a third group receiving standard chemotherapy with gemcitabine and cisplatin plus durvalumab. All therapies are given by intravenous infusion. The study includes an initial safety run-in phase where participants complete at least one 21-day treatment cycle, followed by a randomized portion that will assess overall survival and other efficacy measures over an estimated period of up to 50 months. During the study, participants will undergo assessments including tumor tissue testing to confirm HER2 expression, evaluations of tumor lesions using RECIST criteria, and monitoring of physical function and adverse effects. Blood samples will be collected to analyze drug levels and immune responses. Researchers will track overall survival, progression-free survival, response rates, and patient-reported tolerability throughout the treatment and up to the studys end. The study duration extends until the final data collection, which may be up to several years after enrollment.

This research evaluates the efficacy and safety of rilvegostomig combined with bevacizumab, with or without tremelimumab, compared to atezolizumab with bevacizumab as first-line treatment for participants with advanced hepatocellular carcinoma HCC who cannot undergo curative or locoregional therapies. This Phase III, randomized, open-label, sponsor-blinded, global study includes a safety lead-in period before the randomized phase to assess tolerability. Participants receive treatments through intravenous therapy in one of three groups rilvegostomig with bevacizumab and tremelimumab, rilvegostomig with bevacizumab, or atezolizumab with bevacizumab. The study has two parts the initial safety lead-in to evaluate the combination of rilvegostomig, bevacizumab, and tremelimumab, followed by a randomized period comparing the three treatment arms. Throughout the study, participants are monitored for overall survival and safety outcomes for up to approximately six years. Assessments include evaluation of tumor response, immune response, adverse events, and subgroup analysis based on PD-L1 expression. Participants must meet specific health and disease criteria at screening and will receive regular follow-up during the studys duration.

Researchers are evaluating the effectiveness and safety of the drug RO7771950 combined with trastuzumab and capecitabine compared to tucatinib combined with trastuzumab and capecitabine in people with locally advanced or metastatic HER2-positive breast cancer. This study includes patients with or without central nervous system metastases and focuses on those who have previously received anti-HER2 therapies. The trial is a randomized, open-label study sponsored by Hoffmann-La Roche, designed to assess treatment outcomes in this patient population. Participants will be assigned to one of three groups two experimental arms receiving different doses of RO7771950 orally twice daily, or a comparator arm receiving tucatinib orally twice daily. All participants will also receive trastuzumab, administered either intravenously or subcutaneously according to local guidelines, and capecitabine taken orally twice daily. The study evaluates these treatments over an extended period to monitor their effects on disease progression and safety. During the trial, participants will undergo regular assessments including imaging scans to measure disease progression, evaluations of heart function, and monitoring of symptoms and quality of life. Researchers will track progression-free survival as the primary outcome, along with secondary measures such as overall survival, response rates, treatment-related side effects, and patient-reported outcomes. The total study duration may extend up to several years to capture long-term results and safety data.

Researchers are evaluating the safety and tolerability of tarperprumig in adults diagnosed with or experiencing a relapse of anti-neutrophil cytoplasmic antibody ANCA-associated vasculitis, specifically targeting granulomatosis with polyangiitis GPA and microscopic polyangiitis MPA subtypes. This phase 2 study aims to explore tarperprumigs effects compared to placebo in participants considered for treatment with rituximab or cyclophosphamide. Participants will be randomized to receive one of two dose regimens of tarperprumig or a placebo in a double-blind, parallel-group design. The treatment period lasts up to 70 weeks, during which participants receive their assigned study drug. The study uses a quadruple masking approach to ensure unbiased results and compares safety, tolerability, and efficacy outcomes among groups. Throughout the study, participants will undergo regular assessments including monitoring for treatment-emergent adverse events, evaluations of disease remission status, and measurements of disease activity using the Birmingham Vasculitis Activity Score BVAS. Additional tests include kidney function assessments and proteinuria measurements at baseline and at scheduled weeks. Safety and disease progression will be closely followed up to week 70, with comprehensive data collection on vasculitis damage and relapse occurrences.