Santa Fe De La Vera Cruz

Researchers are evaluating sotatercept as a potential treatment for pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and overworking the heart. PAH symptoms include difficulty breathing and reduced ability to be active. Current standard treatments address symptoms but do not stop disease progression. This Phase 3 study focuses on the long-term safety and tolerability of sotatercept when added to standard PAH therapy. Participants in this long-term follow-up study receive sotatercept through subcutaneous injections every three weeks. Only individuals who completed prior sotatercept PAH studies without early discontinuation may join. This study continues the observation and assessment of participants over an extended period to learn about the effects and safety of sotatercept combined with background PAH treatments. During the study, participants will be regularly monitored for adverse events, treatment discontinuations, and the presence of anti-drug antibodies for up to approximately 90 months. Laboratory tests will evaluate blood components such as platelets, hemoglobin, creatinine, bilirubin, and liver enzymes. Changes from baseline in body weight, blood pressure, and electrocardiogram readings will also be tracked. The study involves adherence to visit schedules and compliance with study procedures to ensure comprehensive long-term safety data collection.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are studying the safety and tolerability of budoprutug, a humanized monoclonal antibody that targets CD19 cells, in adults with primary membranous nephropathy (PMN). This Phase 2, open-label, multicenter trial focuses on patients who are anti-PLA2R antibody positive and continue to have proteinuria despite optimized RAAS inhibition. The study aims to evaluate three different intravenous dose regimens of budoprutug and their effects on this specific kidney condition. Participants will receive budoprutug through single intravenous doses on Day 1, Day 15, Day 169, and Day 183 within one of three sequential dose groups. Approximately 45 subjects will be enrolled, each receiving treatment according to their assigned dosing schedule. The study includes a follow-up period through Week 48, with additional monitoring for B-cell recovery as needed. During the study, participants will undergo safety assessments including monitoring for treatment-emergent adverse events up to 48 weeks. Researchers will also evaluate pharmacodynamics and preliminary efficacy through laboratory tests and clinical evaluations. Regular visits will include tests for kidney function, protein levels in urine, and blood cell counts, alongside other health assessments to ensure participant safety and gather data on how the drug affects the disease.

Researchers are investigating the effects of two different doses of Glycopyrronium (GP) metered dose inhaler (MDI) compared to a placebo MDI when added to background treatment with Budesonide and Formoterol Fumarate (BFF) MDI. This study focuses on children aged 4 to less than 12 years who have asthma. The goal is to assess how these treatments affect lung function in this pediatric population during a Phase II clinical trial. The study is designed as a multi-center, randomized, double-blind, 3-period, 6-sequence crossover trial. It begins with a 3-week run-in period, followed by three separate 3-week treatment periods during which participants receive one of the three treatments: BFF MDI plus GP MDI Dose A, BFF MDI plus GP MDI Dose B, or BFF MDI plus placebo MDI. All inhalers are taken twice daily via oral inhalation. After completing the treatment periods, participants attend a safety follow-up visit 12 to 16 days after their last dose. Participants will undergo regular assessments including lung function tests to measure Forced Expiratory Volume in one second (FEV1) one hour after dosing at the end of treatment. Researchers will monitor safety through clinical exams and follow-up visits. The total participation duration includes the run-in, treatment periods, and safety follow-up, providing a comprehensive evaluation of the treatments' effects on asthma control in children.

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 investigating the long-term safety and tolerability of open-label iptacopan in adults with primary IgA nephropathy who have previously completed specific clinical trials (CLNP023X2203 or CLNP023A2301). This extension study is designed to allow participants continued access to iptacopan until certain conditions are met, such as reaching three years from the last patient first visit, loss of treatment benefit, negative benefit-risk profile, initiation of dialysis or kidney transplant, or commercial availability of the drug. The study will also assess the drug's effects on disease progression every six months. Participants who completed the prior trials and meet inclusion criteria may receive oral iptacopan capsules at a dose of 200 mg twice daily. The study is open-label and non-randomized and will continue treatment under this regimen until one of the study-defined stopping points is reached. Supportive care with ACE inhibitors or ARBs is maintained as per clinical guidelines, and vaccination against certain infections is required before enrollment. During the study, participants will be monitored for safety, including serious adverse events, adverse events of special interest, vital sign abnormalities, ECG changes, and laboratory test abnormalities from the first day of treatment until seven days after the last dose. Efficacy assessments occur every six months to evaluate clinical effects on disease progression. The study aims to collect long-term safety and tolerability data while providing ongoing treatment access until the drug becomes commercially available or other stopping criteria apply.

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.