Leland

This trial focuses on adults with uncontrolled gout, investigating the effects of pegloticase given with methotrexate (MTX). Researchers aim to compare two ways of delivering pegloticase: subcutaneous (under the skin) and intravenous (into a vein). The main goal is to see how well each method maintains normal levels of serum uric acid during the sixth month of treatment. Participants will be randomly assigned to receive either pegloticase 18 mg by subcutaneous injection every two weeks with MTX or pegloticase 8 mg by intravenous infusion every two weeks with MTX. MTX is taken orally weekly. Both groups are monitored under a double-blind design, meaning neither participants nor researchers know which treatment is given to ensure unbiased results. During the study, participants will have their serum uric acid levels checked regularly, especially at weeks 20 through 24 to assess response. Researchers will also monitor for serious injection site reactions and infusion reactions, including anaphylaxis, up to week 48. The study includes assessments of drug levels in the blood and safety monitoring throughout. Participation lasts at least six months with ongoing evaluations to track efficacy and safety.

Rheumatoid Arthritis (RA) is a long-lasting inflammatory condition that causes joint pain, stiffness, swelling, and loss of function. Researchers are evaluating the effectiveness and safety of targeted treatments for adults with moderately to severely active RA who have not responded adequately to one or two prior biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). This study involves three substudies. Substudy 1 compares lutikizumab given alone to a placebo, Substudy 2 compares ravagalimab alone to a placebo, and Substudy 3 compares a combination of lutikizumab and ravagalimab to a placebo. Participants receive these treatments as subcutaneous injections. Approximately 180 adults will be randomly assigned to one of these treatment groups across about 65 locations worldwide. Participants will attend regular visits at clinics during the study where their response to treatment will be assessed through medical exams, blood tests, side effect monitoring, and questionnaires. The main outcomes measured include the percentage of participants achieving a 50% improvement in symptoms by week 12 and the number of participants experiencing adverse events up to about week 22. The study plans to end in 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 clinical efficacy and safety of sonelokimab compared with placebo in adults with active psoriatic arthritis who have previously shown inadequate response or intolerance to anti-tumor necrosis factor (TNF) alpha therapy. This Phase 3, randomized, double-blind, placebo-controlled study also includes risankizumab as an active reference to further assess treatment options for this condition. Participants are assigned to one of four groups: two different doses of sonelokimab given by subcutaneous injection as an induction regimen of four doses followed by maintenance dosing every four weeks starting at Week 8, a placebo group receiving subcutaneous injections, or a group receiving risankizumab by subcutaneous injection. The study compares the effects of these treatments over time. Throughout the study, participants will undergo regular assessments for improvement in psoriatic arthritis symptoms using the American College of Rheumatology criteria (ACR50 and ACR20) and other measures like Minimal Disease Activity, the Health Assessment Questionnaire Disability Index, Psoriasis Area and Severity Index, and quality of life surveys. Safety and response rates will be closely monitored, with primary outcome measurement at Week 16. The study is expected to continue until January 2027.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.