Falls Church

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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 drugs 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.

This research aims to assess the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty, synthetic bone graft extenders, compared to autogenous bone graft in patients undergoing hindfoot or ankle fusions. The study focuses on treating hindfoot and ankle disorders requiring rigid hardware fixation and supplemental bone graft or substitute. It is a randomized, single-blind, controlled, multi-center phase IV post-marketing study involving adult patients aged 18 to 75 years. Participants will be randomly assigned to receive either MagnetOs PuttyEasypack Putty or autograft harvested from the calcaneus, distal tibia, or proximal tibia along with rigid hardware fixation during surgery. The volume used depends on the joint fused, with 1-5 cc for talonavicular, calcaneocuboid, and subtalar joints, and up to 10 cc for the tibiotalar joint. The surgical procedures include ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion of two of these joints. Participants will be followed up with radiographs at screening and weeks 6, 12, 24, and 52 post-surgery, with CT scans at weeks 24 and 52 to evaluate radiographic fusion. Functional assessments will also be conducted throughout the study period. If secondary surgical interventions occur after six months, CT scans may be adjusted. The primary outcome is radiographic fusion by CT scan at 24 weeks post-operation. Safety and efficacy are monitored for one year after surgery, with weight-bearing X-rays starting at week 12.

This research aims to evaluate 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 compares different doses of CDR132L to a placebo, with treatment assignment determined randomly. It is a phase 2, multicenter, randomized, double-blind, placebo-controlled trial sponsored by Novo Nordisk AS, lasting about 60 weeks. Participants will receive intravenous infusions of one of three doses of CDR132L or placebo once every 4 weeks for 48 weeks. Alongside the study drug or placebo, participants will continue their individually adapted guideline-directed standard of care therapy for heart failure. This treatment period is followed by an extension phase to monitor safety and efficacy. During the study, participants will undergo assessments including measuring the change in normalized microRNA-132-3p levels from baseline to week 24, as well as cardiac magnetic resonance imaging to evaluate heart structure changes and blood tests like NT-proBNP levels. Safety is monitored by recording adverse events up to week 60. The total participation duration is approximately 60 weeks, involving regular infusions and follow-up visits.

Researchers are comparing two chemotherapy treatment plans for patients with newly diagnosed intermediate-risk rhabdomyosarcoma, a type of soft tissue cancer. This phase III trial evaluates whether a higher dose chemotherapy over a shorter time Regimen A is better than a lower dose chemotherapy followed by maintenance treatment over a longer time Regimen B, both combined with standard surgery and radiation. The study also aims to assess survival rates, treatment side effects, and molecular features of the tumor. Participants are randomly assigned to one of two treatment groups. Regimen A involves multiple cycles of vincristine, dactinomycin, and cyclophosphamide given intravenously every 21 days, with possible surgery during week 12 and radiation treatments during specified cycles. Regimen B includes alternating cycles of vincristine, dactinomycin, cyclophosphamide, and irinotecan, followed by 24 weeks of maintenance chemotherapy with vinorelbine and oral cyclophosphamide. Both groups undergo imaging scans and biopsies as needed during treatment. Throughout the study, participants will have regular CT or MRI scans and blood tests, along with other procedures such as lymph node biopsies, bone marrow tests, and lumbar punctures to monitor disease status. After treatment, follow-up visits occur every 3 months for the first year, then less frequently up to 5 years to check for event-free survival and overall health. The trial also collects biospecimens for future research and evaluates treatment effects on fertility and quality of life.

Researchers are evaluating efruxifermin EFX in adults with non-cirrhotic nonalcoholic steatohepatitis NASH or metabolic dysfunction-associated steatohepatitis MASH who have liver fibrosis stage 2 or 3. This Phase 3, multi-center, randomized, double-blind, placebo-controlled study aims to assess the safety and efficacy of EFX compared with placebo. The trial includes about 1,650 participants divided into two cohorts based on liver biopsy characteristics and fibrosis stage. Participants will be randomly assigned to one of three groups EFX 28 mg, EFX 50 mg, or placebo, each given as a weekly subcutaneous injection. Cohort 1 will be evaluated over 52 weeks for histologic efficacy endpoints, while Cohort 2 will have assessments over 96 weeks. After these periods, participants may continue long-term treatment and clinical follow-up for up to approximately 240 weeks total. A follow-up visit will occur about 30 days after the last dose. During the study, participants will undergo liver biopsies, blood tests, and non-invasive assessments such as FibroScan and Enhanced Liver Fibrosis ELF score to monitor liver health and fibrosis. Researchers will track liver-related clinical outcomes, including liver events and survival, as well as safety and tolerability of the treatment. Participants who stop the study drug may still continue with scheduled assessments to support long-term safety and efficacy evaluations.

Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated in adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is being given to humans. The study is a Phase IIIa trial conducted in two parts to investigate safety and tolerability of this treatment. In Part 1, a small group of participants receive low, medium, or high doses of BI 3812465 as injections into the back of the eye. Participants starting later receive higher doses only if lower doses are tolerated. In Part 2, a larger group is randomized into low, medium, or high dose groups, also receiving three eye injections of BI 3812465. The treatment is given sequentially with dose escalation based on safety. Participants stay in the study for up to seven months, attending 19 visits to the study site, with some visits possibly conducted at home. During these visits, doctors assess the severity of the eye condition and monitor any health problems related to the treatment. The study measures safety outcomes including dose limiting events and ocular adverse events over up to 169 days after treatment starts.