Palm Beach Gardens

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

This research aims to evaluate the effectiveness, safety, and tolerability of DermaBind TL, a full-thickness dehydrated placental allograft, in patients with chronic non-healing ulcers, including diabetic foot ulcers DFUs and venous leg ulcers VLUs. The trial focuses on patients whose wounds have not responded to standard treatments. The study is a prospective, multi-center, open-label, single-arm clinical trial led by HealthTech Wound Care, designed to collect outcome data over a 12-week treatment period. Participants will receive DermaBind TL applied to their wounds while following standard care, including offloading with devices like CAM boots or total contact casting, wound debridement, infection management, and layered dressings for protection. The treatment phase lasts 12 weeks with assessments for wound area protection, infection rates, and adverse events. The study includes a screening phase to determine eligibility before treatment begins. During the study, clinicians will assess wounds regularly to monitor wound size, infection, and healing progress. Data will be collected on the number of grafts used and any treatment-related adverse effects. Outcome measures include wound area preservation and protective effects of the dressing over 13 weeks. Participants must comply with offloading and dressing protocols and will be followed for safety and treatment tolerability throughout the study duration.

Researchers are evaluating the effectiveness and safety of current standard treatments for adults with active systemic lupus erythematosus SLE, including lupus nephritis, who have not responded adequately to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with ongoing active disease despite prior treatments, aiming to better understand treatment outcomes in this population. The study is observational and sponsored by Bristol-Myers Squibb. Participants will continue to receive their current standard of care treatments as prescribed, which may include biologic therapies and other immunosuppressants, according to product labels and treatment guidelines. Those with lupus nephritis must have had a recent renal biopsy confirming specific kidney involvement. The study observes participants over time without altering their treatment, collecting data on disease activity and response. During the study, participants will be monitored regularly for up to five years. Assessments include clinical evaluations, laboratory tests, and disease activity questionnaires to track remission status, kidney function, disease flare-ups, and fatigue levels. The primary outcome is the number of participants achieving remission at six months. Secondary outcomes include long-term remission, kidney response, disease activity states, and patient-reported fatigue. Safety and treatment response duration will also be recorded throughout the study period.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are evaluating targeted therapies to treat adults with moderately to severely active Rheumatoid Arthritis RA, a chronic inflammatory condition causing joint pain, stiffness, swelling, and loss of function. This Phase 2 study involves three substudies focusing on different drug treatments to assess their effectiveness and safety for participants who have not responded to one or two prior biologic or targeted synthetic DMARD therapies. Participants will be randomly assigned to receive one of several treatments lutikizumab alone, ravagalimab alone, a combination of lutikizumab and ravagalimab, or matching placebos. These drugs are given by subcutaneous injection. The study involves regular visits at hospitals or clinics where participants receive the assigned treatment and are monitored closely. The treatment period and detailed dosing schedules are part of the studys design. During the trial, participants will undergo medical assessments, blood tests, and questionnaires to monitor treatment effects, side effects, and disease activity. The main outcomes measured include the percentage of participants achieving a 50% improvement according to the American College of Rheumatology criteria by Week 12 and the number of adverse events up to approximately Week 22. Participants will attend regular visits for evaluations throughout the study period, which is expected to complete by November 2027.

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 evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are observing how avacincaptad pegol is used in routine clinical practice for people with geographic atrophy caused by age-related macular degeneration AMD. Geographic atrophy is an advanced form of AMD where retinal cells waste away, leading to worsening central vision and potential permanent vision loss. This observational study collects information on treatment and medical events related to avacincaptad pegol without influencing the doctors treatment decisions. Participants in this study have chosen to begin treatment with avacincaptad pegol, delivered as intravitreal injections into the eye. The study records how often and how long the treatment is given, along with reasons for stopping treatment. It monitors participants receiving this treatment in one or both eyes as part of their regular medical care, without additional interventions from the study. During the study, participants will have eye exams as part of their usual care and will complete surveys about their eye health at the start of treatment, every six months for two years, and then yearly. Researchers will gather data from medical records to track treatment usage, vision changes, and any adverse events for up to about five years. This long-term observation helps understand real-world treatment patterns and safety.

The trial investigates treatments for Fuchs endothelial dystrophy, a condition affecting the corneas inner layer. It is a Phase 3, multi-center, randomized clinical trial comparing two surgical approaches for this condition. The goal is to better understand how different procedures affect vision and eye health in adults with this disease. The study is led by Stanford University and includes 60 participants who will be randomly assigned to treatment groups with masked outcome assessors to reduce bias. Participants will be randomly assigned to one of two groups one receiving Descemet Membrane Endothelial Keratoplasty DMEK with a topical placebo, and the other undergoing Descemet Stripping Only DSO combined with topical Ripasudil 0.4%. The study is triple-masked, meaning patients, surgeons, and outcome assessors are unaware of the treatment assignments. Both treatments are delivered as eye procedures, and the Ripasudil is administered topically to the eye in the DSO group. During the 24-month study period, participants will undergo regular assessments including measuring their best spectacle-corrected visual acuity BSCVA at 3, 6, 12, and 24 months. Endothelial cell density will also be measured at 3, 6, and 24 months to monitor the corneas cell health. Safety and adherence to the protocol will be monitored throughout to ensure accurate evaluation of each treatments outcomes. Participants will be followed closely to assess the impact of treatments on vision and corneal health over time.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.