Leland

Researchers are evaluating the effectiveness of pegloticase administered by two different methodssubcutaneous under the skin injection versus intravenous into a vein infusioneach combined with methotrexate MTX in participants who have uncontrolled gout. The main goal is to compare how well these two treatment methods maintain normal serum uric acid levels over a six-month period. This Phase 3 trial is designed as a double-blind, randomized controlled study to provide reliable information on treatment responses.

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.

This clinical trial is studying BRM424 ophthalmic solution in patients with Neurotrophic Keratitis NK, specifically those with Stage 2 and Stage 3 of the condition. The study aims to evaluate the initial effectiveness of BRM424 in healing persistent epithelial defects PED or corneal ulcers and to assess its safety and tolerability. The trial is a Phase 2, randomized, open-label study sponsored by BRIM Biotechnology Inc. Participants will receive one of two doses of BRM424 ophthalmic solution, administered as topical eye drops. The study does not include a placebo group and involves two active comparator arms. The treatment period is 28 days, during which patients will use the assigned dose of BRM424. The study is conducted across multiple centers and does not involve masking or blinding. Participants will be monitored for healing progress using corneal fluorescein staining to assess complete healing of the PED or corneal ulcer within four weeks. Safety and tolerability assessments will also be conducted throughout the treatment period. The trial will track the proportion of patients achieving complete healing as the primary outcome measure. Participation is expected to last at least four weeks, with evaluations focusing on eye health and treatment response.

Researchers are evaluating the effectiveness and safety of a single injection of AURN001 compared to a placebo in adults with corneal edema caused by corneal endothelial dysfunction. This randomized, double-masked Phase 3 study focuses on improving vision in participants who have this eye condition and may require surgery. Participants will receive either a single dose of AURN001 or a single dose of a placebo, both injected into the anterior chamber of the eye. The study uses a quadruple masking design to ensure unbiased results, comparing these two groups to assess changes in vision and corneal thickness over six months. During the study, participants best corrected visual acuity BCVA and central corneal thickness CCT will be measured at the start and again at six months. The main outcome is the percentage of participants who improve their vision by at least 15 letters on the ETDRS scale at six months. Safety and other changes in eye health will also be monitored throughout the trial, which is expected to continue until January 2028.

Researchers are evaluating the investigational drug PLG0206 to see if it can reduce the recurrence of infection in adults who have had a total knee replacement and are receiving a DAIR Debridement, Antibiotics, and Implant Retention surgical procedure to treat a Prosthetic Joint Infection PJI. This Phase 23 study also aims to assess the safety of using PLG0206 as an irrigation solution during the DAIR surgery. Participants will undergo a DAIR procedure following their hospitals standard care. After debridement, a single dose of either PLG0206 or a placebo will be administered as an intra-articular irrigation during the surgery. Following this, all participants will receive standard post-operative care, including possible intravenous or oral antibiotics. The study drug is given only once during the procedure. Participants will be monitored for safety and any signs of infection recurrence for one year after the study drug administration. Follow-up includes in-clinic visits on Days 14, 90, and 365, along with telephone or virtual visits on Days 30, 180, and 270. Researchers will measure treatment failure, infection recurrence, clinical outcomes, safety, microbiological effects, and changes in function and biomarkers during this period.

Researchers are evaluating sonelokimab in adults with active psoriatic arthritis who have not had adequate results or could not tolerate prior anti-tumor necrosis factor TNF alpha therapy. This Phase 3, multicenter, randomized, double-blind study compares the safety and effectiveness of two doses of sonelokimab against placebo and an active reference treatment called risankizumab. Participants are randomly assigned to one of four groups one receiving sonelokimab dose 1, another receiving sonelokimab dose 2, one receiving placebo, and one receiving risankizumab. Those in the sonelokimab groups receive four initial subcutaneous doses as induction, then maintenance doses every four weeks starting at Week 8. The placebo and risankizumab groups receive their respective treatments subcutaneously according to the study protocol. During the study, participants will undergo assessments of joint tenderness and swelling, skin psoriasis activity, physical function, and quality of life at Week 16. Researchers will monitor response rates based on improvement criteria such as the American College of Rheumatology 50% improvement ACR50. Safety and tolerability will also be followed throughout the trial, which is expected to complete by January 2027.

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.