Tinley Park

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 disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Researchers are evaluating a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

This clinical trial is investigating iloperidone as a potential treatment for people with uncontrolled hypertension, a condition where blood pressure remains high despite treatment. The study is designed as a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate both the effectiveness and safety of iloperidone for this condition. Participants will be randomly assigned to receive either iloperidone or a placebo. The study involves careful monitoring over a treatment period of 4 weeks to assess changes in systolic blood pressure. Both the experimental drug and placebo are given under controlled conditions, and neither the participants nor the researchers know who receives which. During the study, participants systolic blood pressure will be measured from baseline through week 4 to evaluate treatment response. Safety and any side effects will be monitored closely. The total study duration includes initial screening followed by the 4-week treatment period. Participants will have regular visits for blood pressure measurements and health assessments throughout the trial.

This research aims to evaluate the efficacy, safety, and tolerability of Suzetrigine in adults experiencing pain related to diabetic peripheral neuropathy DPN. The study focuses on participants with type 1 or type 2 diabetes who have had bilateral lower extremity pain from DPN for at least one year, seeking to understand how Suzetrigine impacts their pain levels compared to placebo. Participants will be randomly assigned to one of two groups those receiving Suzetrigine tablets and those receiving a matching placebo, both taken orally. The study uses a parallel design and is conducted in a double-blind manner to assess the treatment effects over a 12-week period. During the study, participants will have their daily pain intensity measured using the Numeric Pain Rating Scale NPRS and physical health status assessed via the SF-36 questionnaire. Researchers will monitor changes from baseline to week 12 to evaluate the treatment impact. The study spans from screening through 12 weeks of treatment, with safety and tolerability closely observed throughout this period.

Researchers are conducting a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-14 esreboxetine in managing fibromyalgia. The study aims to understand how well AXS-14 works for people with fibromyalgia by comparing continued treatment to placebo after an initial response. This multi-center trial is sponsored by Axsome Therapeutics, Inc. The study includes a 12-week open-label period where all participants receive AXS-14 tablets once daily. Those who respond to treatment will then enter a 12-week double-blind, placebo-controlled randomized withdrawal period. During this phase, participants are randomly assigned to either continue AXS-14 or switch to placebo until a loss of therapeutic response occurs or the period ends. Participants will be closely monitored throughout both study periods. Researchers will assess the time from randomization to loss of therapeutic response over 12 weeks. The study involves regular evaluations to track safety and treatment effects. Total participation spans up to 24 weeks, including both treatment phases.

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 evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.