West Long Branch

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 efficacy of dotinurad compared with allopurinol in lowering serum uric acid sUA levels in adults with tophaceous gout. This Phase 3 trial focuses on adult participants aged 18 to 75 years who have measurable tophi and a diagnosis of gout for at least one year. The study aims to assess how well dotinurad reduces sUA levels at Week 24 compared to allopurinol, an established treatment for this condition. Participants are randomly assigned to one of two treatment groups. One group will stop their current allopurinol and continue with study-supplied allopurinol once daily through Week 76. The other group will discontinue allopurinol and start dotinurad at 1 mg daily for the first 4 weeks, then increase to 2 mg daily for the next 8 weeks, and finally 4 mg daily thereafter until Week 76. Both treatments are given as oral tablets, and participants are closely monitored throughout the study. During the study, participants will undergo various assessments including blood tests to measure serum uric acid levels at multiple time points, evaluation of tophi response, and tracking of gout flare frequency and severity. Safety monitoring will include recording any adverse events and serious side effects up to Week 80. The main outcome measures focus on the percentage of participants achieving target sUA levels at Week 24 and clinical responses in tophi at Week 76, with ongoing evaluations up to Week 80 to assess longer-term effects and safety.

Researchers are studying ML-007C-MA to assess its safety and effectiveness in treating hallucinations and delusions in adults aged 55 to 90 who have Alzheimers Disease Psychosis ADP. This phase 2 randomized, double-blind, placebo-controlled trial aims to compare ML-007C-MA with a placebo by measuring changes in specific symptoms using the Neuropsychiatric Inventory-Clinician NPI-C Hallucinations and Delusions score. Participants will be randomly assigned to receive either ML-007C-MA at doses of 1051.5 mg or 2103 mg twice daily, or placebo tablets. The treatment period lasts 7 weeks, during which the study will monitor symptom changes and safety. The study includes adults with confirmed ADP and psychotic symptoms who have a designated care partner to help with symptom reporting and medication adherence. Throughout the trial, participants will undergo assessments including the NPI-C Hallucinations and Delusions score, Clinical Global Impressions-Severity CGI-S scale, and Mini-mental State Examination MMSE. These evaluations occur at the start and end of the 7-week treatment to measure symptom changes. Safety monitoring and adherence tracking will be part of the study, which is scheduled to complete by December 2027.

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 efficacy and safety of a combination of KarXT and KarX-EC to treat cognitive impairment in individuals with mild to moderate Alzheimers Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to understand how these treatments affect thinking and memory problems associated with Alzheimers. The study is sponsored by Bristol-Myers Squibb and focuses on participants aged 60 to 85 years diagnosed according to specific clinical criteria and biomarkers. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. The medications are given at specified doses on designated days, though exact dosing schedules are not detailed in the summary. The study follows a parallel-group design, comparing the effects of the active drugs against placebo over a treatment period lasting 24 weeks. During the study, participants and their caregivers will attend visits where cognitive function and daily living abilities are assessed using tools such as the Alzheimers Disease Assessment Scale-Cognitive Subscale ADAS-Cog11 and Clinicians Interview-Based Impression Plus Caregiver Input CIBIC. Safety is closely monitored through reports of adverse events, vital signs, laboratory tests, ECGs, and other clinical evaluations. The study lasts through the treatment period up to 24 weeks, with continuous monitoring of participant health and cognitive changes.

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.

This research aims to evaluate the effectiveness and safety of LUPKYNIS combined with belimumab, obinutuzumab, or anifrolumab in adults with lupus nephritis LN. The study focuses on how well these combinations induce a rapid kidney response in patients diagnosed with LN, a condition affecting kidney health. It is a phase 4 clinical trial sponsored by Aurinia Pharmaceuticals Inc. that assesses treatment approaches for this condition. Participants will receive LUPKYNIS along with one of the biologic agents belimumab, obinutuzumab, or anifrolumab. In addition, all patients will be treated with a mycophenolic acid analog MPAA, such as mycophenolate mofetil or mycophenolic acid, and corticosteroids like prednisone or an equivalent. The biologic treatment schedules vary depending on the specific drug, with some patients already receiving treatment before the study starts or beginning it at the start of the trial. During the study, participants will be monitored for kidney response over 24 weeks, including complete and partial renal responses. Researchers will assess safety by tracking treatment-emergent adverse events up to 28 weeks. Other assessments include measuring changes in kidney-related antibodies and complement levels at baseline, 12 weeks, and 24 weeks. The total participation duration extends to about 28 weeks, during which various evaluations, laboratory tests, and safety monitoring will occur to understand treatment effects and patient outcomes.

Researchers are investigating the use of the GalaFLEX LITE Scaffold in revision surgeries for women who experience capsular contracture, a common complication after breast implant augmentation. This study compares the scaffold to standard revision surgery without any supportive matrix or acellular dermal matrix ADM, aiming to reduce the recurrence of capsular contracture and implant malposition. The trial is prospective, randomized, and controlled, involving women with Baker grade III or IV capsular contracture. Participants will be randomly assigned in a 21 ratio to receive surgery either with the GalaFLEX LITE Scaffold, a bioabsorbable surgical mesh made from poly-4-hydroxybutyrate P4HB designed to reinforce soft tissue, or standard surgery without any scaffold. The number of treated breasts will range between 250 and 530. The study uses an adaptive design and includes a follow-up of up to 24 months to assess outcomes. During the study, participants will be monitored through various visits over two years. Researchers will evaluate the scaffolds effectiveness in stabilizing the implant pocket, reduce capsular contracture recurrence or implant malposition, and assess safety within 90 days post-surgery. Quality of life and patient satisfaction will also be measured at 12 and 24 months. Participants will complete an electronic patient diary using compatible smart technology and attend scheduled study visits to support adherence and data collection.