Apple Valley

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the effects of two oral drugs, ECC4703 and ECC0509, alone and in combination, on reducing liver fat in adults with presumed Metabolic Dysfunction-associated Steatohepatitis MASH. This phase 2a trial compares low and high doses of each drug and their combination with a placebo to assess changes in liver fat using MRI at 12 weeks. Participants are randomly assigned to one of several groups receiving either placebo, low or high doses of ECC4703, low or high doses of ECC0509, or a combination of high doses of both drugs. Each treatment is given as oral capsules. The main study period lasts 12 weeks during which participants take the assigned capsules and undergo evaluations. During the trial, participants will have multiple assessments including MRI scans to measure liver fat, blood tests to monitor liver enzymes and metabolic markers, and quality of life questionnaires. Drug levels in the blood will be measured at several time points. The study measures liver fat reduction primarily at 12 weeks and monitors safety and various biochemical markers throughout the period.

Researchers are evaluating the safety and effectiveness of induction therapy using Afimkibart also called RO7790121 in people with moderately to severely active ulcerative colitis UC. This Phase III study is designed as a multicenter, double-blind, placebo-controlled trial to compare Afimkibart with a placebo. The study aims to understand how well Afimkibart works to induce remission in UC and its safety profile. Participants will be randomly assigned to one of two groups. One group will receive Afimkibart through an intravenous IV infusion followed by a subcutaneous SC injection, while the other group will receive matching placebo infusions and injections. The treatment period lasts 12 weeks, during which researchers will assess the effects of the therapies. Throughout the study, participants will undergo various assessments including evaluations of clinical remission, endoscopic improvement, histologic changes, and symptom severity at specified time points such as baseline, Week 2, and Week 12. Safety will be monitored by tracking adverse events for up to 30 weeks after starting treatment. The total participation duration spans the treatment and follow-up periods to gather comprehensive data on outcomes and safety.

Migraines cause severe throbbing or pulsating headaches, often on one side of the head, and are linked with nausea and sensitivity to light and sound. This study evaluates Corabotase IPN10200, a medication designed to prevent episodic and chronic migraines by blocking the release of chemicals that cause pain. The research aims to assess the safety, optimal dosing, and effectiveness of Corabotase injections into head and neck muscles. The trial has three periods an initial screening to confirm participant eligibility Step 1, where two doses of Corabotase are tested sequentially in separate cohorts against placebo, with injections administered into head, face, and neck muscles, and safety monitored for 36 weeks and Step 2, where new participants with episodic or chronic migraine are randomly assigned to receive either Dose A, Dose B, or placebo, with injections given in the same muscle areas and both safety and effectiveness tracked until Week 36. Participants complete a daily electronic migraine diary and questionnaires throughout the study, which lasts up to 44 weeks. Researchers monitor adverse events, lab and vital sign changes, facial exams, ECG readings, suicidal behavior, and antibody responses. The main outcome is the reduction in monthly migraine days by Week 12, with ongoing evaluation of headache frequency, medication use, and safety measures through Week 36.

Researchers are evaluating the effectiveness of adding tirzepatide to ongoing ixekizumab therapy in adults with active psoriatic arthritis PsA who are overweight or obese and have at least one weight-related health condition. This Phase 4 study aims to assess how well this combination works in real-world clinical practice over a 12-month period. Participants will continue their current ixekizumab treatment and begin taking tirzepatide, which is administered by subcutaneous injection as directed by the medication label. The study involves a single treatment group where all participants receive this combination therapy, with treatment lasting up to 12 months. During the study, participants will be monitored regularly to assess joint symptoms, skin involvement, disease activity, pain, fatigue, physical and mental health, and weight changes. Researchers will collect data at multiple time points, including baseline, 6 months, and 12 months, using questionnaires, joint counts, and physical assessments. The primary outcomes focus on improvements in disability and weight loss after 12 months of therapy.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are evaluating bimekizumab administered intravenously compared to subcutaneous injection in adults with active psoriatic arthritis or active axial spondyloarthritis. The study aims to show that the intravenous method is not less effective than the subcutaneous method by assessing how the drug moves in the body over time. This is a Phase 1, open-label, randomized, parallel-group study focused on treatment. Participants will receive one of three dosing regimens of bimekizumab during a pharmacokinetics lead-in phase and continue with the same assigned regimen during the treatment period. The dosing regimens include intravenous and subcutaneous administration of bimekizumab at specified times. Subjects are randomized into one of two experimental arms reflecting different intravenous regimens or a third arm receiving the subcutaneous regimen. During the study, participants will be monitored for steady-state trough concentration of the drug at week 16. Safety is assessed by tracking treatment-emergent adverse events, serious adverse events, and any events leading to withdrawal from the study through week 29. The study duration extends to the end of safety follow-up, with regular assessments to evaluate drug levels and participant health under medical supervision.

Central Line-Associated Bloodstream Infections CLABSIs are a serious problem in U.S. hospitals, leading to higher death rates, longer hospital stays, and increased costs. This research evaluates whether a machine learning ML model that predicts possible CLABSI risk can help Infection Preventionists IPs reduce infection rates compared to usual practices. The study is a prospective, multi-center, cluster-randomized trial conducted in 20 hospitals with the highest CLABSI rates. In this trial, hospitals are split into early and late groups. Early hospitals get access to the ML model via a daily dashboard that flags high-risk patients. Infection Preventionists use this information to provide targeted education and recommend best practices for central line care, including line removal when appropriate. The model was built using extensive patient data and predicts infection risk with high accuracy. The control hospitals continue with routine clinical practice without access to the model during the study period. Participants are hospitalized adults with central lines, and the model scores patients daily if their line has been in place for over 48 hours. Researchers monitor CLABSI rates per 1,000 central line-days, central line removals within 48 hours of alerts, positive blood culture rates, and IP intervention frequencies. Safety outcomes such as pneumothorax and hemorrhage are also tracked. The study duration is about five months with interim and final analyses planned to assess the impact of providing the ML model to Infection Preventionists.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are studying the safety and tolerability of NTR-1011, a fusion protein designed to reduce inflammation by clearing neutrophil extracellular traps, in adults with systemic lupus erythematosus SLE and rheumatoid arthritis RA, as well as in healthy adult volunteers. This Phase 1ab clinical trial aims to determine the highest safe dose of NTR-1011 given either under the skin or intravenously, understand how the body processes the drug, assess immune response to it, and explore early signs of benefit when added to standard treatments. The study has two parts Phase 1a, completed with healthy volunteers receiving single doses of NTR-1011 or placebo via intravenous or subcutaneous routes and Phase 1b, currently recruiting adults with moderate-to-severe SLE or RA who receive five weekly intravenous doses of NTR-1011 alongside their usual care. Dose levels in Phase 1b are adjusted based on safety and response data. No placebo group exists in Phase 1b, and participants are assigned to either the SLE or RA group. Participants undergo physical exams, lab tests, vital sign monitoring, and blood sampling to measure drug levels, immune markers, and antibodies against NTR-1011. Clinical assessments include disease activity scores and patient-reported outcomes specific to SLE and RA. Safety and tolerability are closely monitored throughout treatment and for four weeks after the last dose. The studys findings will help guide future development and dosing of NTR-1011 for autoimmune diseases.