Falls Church

Researchers are studying people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity (FVC), over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatment's long-term safety and effects.

Researchers are evaluating the safety and effectiveness of pulsed field ablation (PFA) therapy for treating persistent atrial fibrillation (PersAF) that does not respond to medication. This study compares two approaches: PFA targeting the pulmonary veins plus electrographic flow (EGF) identified extra-pulmonary vein sources, and PFA targeting the pulmonary veins plus the left atrial posterior wall. The goal is to see if the new method with EGF mapping is at least as effective as the standard approach in managing symptoms of PersAF. Participants will be randomly assigned to one of two groups. The control group will receive pulmonary vein isolation (PVI) plus posterior wall ablation (PWA) using PFA, with EGF mapping performed but not used for treatment decisions. The treatment group will receive PVI plus ablation of active sources identified by EGF mapping. The FARAPOINT catheter may be used for narrow posterior wall channels if found. All subjects will undergo mapping and ablation with devices including the FARAPULSE PFA system and Opal HDx mapping system. Ablation procedures and mapping will be performed according to protocol. During the study, participants will be monitored for safety up to 60 days and effectiveness up to 365 days after treatment. Follow-up will include assessments to track heart rhythm and symptoms, with the use of a LUX-Dx insertable cardiac monitor for continuous monitoring. Participants must be able to comply with follow-up visits and device usage instructions. The study aims to capture data on safety outcomes and measure how well the ablation controls atrial fibrillation over one year.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly subcutaneous injection, on slowing the progression of calcific aortic valve stenosis in adults aged 50 to under 80 years with elevated Lipoprotein(a) levels. This phase 2, randomized, double-blind, placebo-controlled multicenter trial aims to assess the efficacy, safety, and tolerability of pelacarsen compared to a matching placebo. The study is sponsored by Novartis Pharmaceuticals and focuses on patients with mild to moderate calcific aortic valve stenosis who are optimally treated for cardiovascular risk factors. Participants receive either pelacarsen 80 mg or a placebo via a prefilled syringe injected under the skin once every month. The study includes two groups: one receiving the active drug and the other receiving a placebo, both administered in the same way. The trial will last up to 36 months, during which patients will be monitored for changes in aortic valve function and calcium levels. Throughout the study, participants will undergo evaluations including measurement of peak aortic jet velocity and aortic valve calcium scores at 36 months. Additional assessments include changes in Lipoprotein(a) levels at 12 months and monitoring of fibrocalcific thickening of the valve and clinical events over the course of the trial. Safety will be closely monitored to ensure participants' well-being during the entire study period.

Researchers are evaluating LNCB74, an antibody drug conjugate, in participants with advanced solid tumors including ovarian, breast, endometrial, biliary tract, and non-small cell lung cancers. This phase 1, open-label study aims to determine the safety, tolerability, and the recommended dose for future studies by escalating doses and expanding treatment in selected tumor types. The study is sponsored by NextCure, Inc. and focuses on participants with measurable disease and adequate organ function. Participants will receive LNCB74 intravenously every 21 days in two parts: Part 1 involves dose escalation to find the maximum tolerated dose or recommended phase 2 dose, with additional safety and biomarker assessments. Part 2 involves dose expansion and optimization to further evaluate safety, tolerability, anti-tumor activity, and pharmacodynamics in a more uniform group of participants. Treatment continues unless unacceptable side effects or clear disease progression occur. During the study, participants will undergo regular safety and response evaluations including tumor assessments, biomarker analysis, and pharmacokinetic measurements. Key outcomes include safety, tolerability, response rates, and progression-free survival over up to 24 months. Blood samples will be taken to study drug levels and immune response. Participants are monitored closely for adverse effects and effectiveness, with a minimum life expectancy of 12 weeks required to join.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating the use of memantine, a single drug, in patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who also have cirrhosis and are not candidates for intensive systemic therapy. This prospective study aims to describe the drug's effects on disease progression and quality of life over time. The study is sponsored by Inova Health Care Services and focuses on patients with a Child-Pugh cirrhosis score of B7 or higher and an Eastern Cooperative Oncology Group performance status of 0-2. Participants will receive memantine starting at 5 mg by mouth once daily, with doses increased up to 20 mg daily as tolerated. The study is conducted at a single site and follows patients through treatment to assess efficacy endpoints, including progression-free survival at 6 months. The treatment plan excludes aggressive systemic therapies and allows palliative radiation for symptom control. During the study, participants will be monitored for disease progression and quality of life changes. Assessments include measuring tumor lesions by RECIST 1.1 criteria and ensuring adequate blood counts and organ function. Safety is closely observed, especially regarding pregnancy risks, cardiovascular health, and other medical conditions. The study continues until August 31, 2026, with ongoing evaluations at defined intervals.

Researchers are evaluating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure who have preserved ejection fraction and left ventricular hypertrophy. The study is a Phase 2, randomized, placebo-controlled trial lasting about 60 weeks, aiming to understand the impact of different doses of CDR132L on heart remodeling and related biomarkers. Participants will be randomly assigned to receive one of three different doses of CDR132L or a placebo. Each treatment is given as an intravenous infusion once every four weeks for 48 weeks. Alongside the study treatment, participants will continue their individually adjusted standard care therapy for heart failure. The trial includes a main phase and an extension phase to monitor effects over time. During the study, participants will undergo various assessments including measurement of microRNA-132-3p levels from baseline to week 24, heart imaging scans to evaluate changes in heart muscle and atrial volume, and monitoring of NT-proBNP levels, a marker of heart failure. Safety is closely tracked by recording adverse events during both the main and extension phases. The entire participation period spans approximately 60 weeks, with ongoing evaluation of the heart's structure and function.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk A/S, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist: one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the safety of atezolizumab alone or combined with bevacizumab as first-line treatments for participants with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC) who have Child-Pugh B7 or B8 liver cirrhosis. This Phase II, open-label study focuses on patients who have not received previous systemic therapy in this setting and aims to assess treatment safety in this specific population. Participants are assigned to one of two groups: Cohort A receives atezolizumab plus bevacizumab, and Cohort B receives atezolizumab alone. Both drugs are given by intravenous infusion every 21 days, with atezolizumab dosed at 1200 mg and bevacizumab at 15 mg/kg. Treatment continues until unacceptable side effects or loss of clinical benefit occur, as determined by the investigator. During the study, participants undergo regular assessments to monitor safety and treatment effects, including tracking adverse events from the start of treatment up to about 36 months. Evaluations include clinical exams, laboratory tests, and imaging to measure disease status. The study also monitors liver function and overall health, with follow-up visits to ensure participant safety throughout the trial period.

Researchers are evaluating the safety and effectiveness of efruxifermin (EFX) in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study will involve about 1,650 participants divided into two groups based on fibrosis stage and will use a randomized, double-blind, placebo-controlled design. Participants will be assigned to receive either 28 mg or 50 mg of efruxifermin or a placebo, all given by weekly subcutaneous injection. The study includes a screening period of up to 12 weeks, a 52-week primary treatment phase, and long-term follow-up that may last up to approximately 240 weeks. Liver biopsies and other assessments will be done at specific times, including weeks 52, 96, and 240, to evaluate liver changes and treatment effects. Throughout the study, participants will undergo various assessments such as liver biopsies, blood tests, FibroScan scans, and questionnaires to monitor liver health, fibrosis progression, and overall safety. Researchers will track outcomes like resolution of NASH/MASH, fibrosis improvement, liver-related events, and survival over the long term. After the last dose, participants will have a follow-up visit about 30 days later to check their condition.