Temecula

Researchers are evaluating the short-term and long-term effects and safety of belimumab in adults with early systemic lupus erythematosus SLE who have positive autoantibodies and ongoing disease activity despite stable first-line treatment. This is a prospective, open-label, single-arm Phase 4 clinical study sponsored by GlaxoSmithKline. The study focuses on adults diagnosed within two years with active SLE, aiming to better understand how belimumab works in this group. Participants will receive belimumab GSK1550188 administered subcutaneously throughout the study. The treatment and observation period lasts for three years, with key evaluations at one year and longer-term follow-ups up to three years. There is no placebo or comparison group, as all participants receive the study drug. During the study, participants will have regular visits to assess disease activity, including the Lupus Low Disease Activity State LLDAS at week 52 and other measures such as the SLE Responder Index 4 SRI4, flare frequency, and improvements in skin symptoms. Researchers will monitor safety by tracking adverse events and serious adverse events. Blood tests, questionnaires, and physical assessments will be done to evaluate fatigue, damage, and disease remission. Participants will be followed for up to 156 weeks to assess long-term outcomes and safety.

Major depressive disorder MDD is a mood disorder causing ongoing sadness and loss of interest, with emotional and physical symptoms such as irritability, difficulty focusing, tiredness, and changes in eating habits. Researchers are studying oral Icalcaprant, an investigational drug, to assess its effects on disease activity and side effects in adults currently experiencing a major depressive episode. Participants are randomly assigned to one of three groups two different doses of Icalcaprant or a placebo. They will take oral capsules once daily for 6 weeks, followed by a 30-day safety follow-up period. The study is conducted at about 35 sites across North America and involves approximately 195 adults. During the study, participants will attend regular visits at a hospital or clinic where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in depression severity using scales like the Montgomery-sberg Depression Rating Scale MADRS over about 6 weeks, and adverse events will be monitored for up to 10 weeks total.

Researchers are investigating the treatment outcomes of subcutaneous anifrolumab 120 mg given once weekly as add-on therapy to antimalarials, with or without glucocorticoids GCs, in patients with systemic lupus erythematosus SLE who have not previously received immunosuppressants or biologic therapies and are not in low disease activity status at enrollment. This Phase 3, multinational, open-label study aims to better understand remission rates, including DORIS remission, and the ability to taper and withdraw chronic GCs in this patient group. Participants will receive anifrolumab administered subcutaneously once weekly for 52 weeks using an autoinjector pen. The study includes a screening period of up to 35 days before treatment starts. For patients on higher doses of GCs at baseline, a structured tapering protocol will be followed from week 5 to week 40, aiming to reduce GC doses to 5 mgday and potentially withdraw GCs completely after sustained remission. After week 40, no further GC dose reductions will occur. An additional 12-week safety follow-up is planned for participants who discontinue anifrolumab after week 52. During the study, participants will undergo regular assessments including clinical evaluations, quality of life and fatigue questionnaires, and laboratory tests to monitor disease activity and remission status. Researchers will measure outcomes such as attainment and duration of DORIS remission, low disease activity, flare incidence, and changes in GC use. Safety will be monitored throughout treatment and in the follow-up period. The total study duration for participants is approximately 69 weeks, including screening, treatment, and safety follow-up.

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 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.

Researchers are evaluating the MINI system, a non-invasive ultrasound device designed to reduce inflammation by stimulating the spleen in adults with active, moderate to severe rheumatoid arthritis who have not responded well or are intolerant to conventional synthetic, biologic, or targeted synthetic DMARDs. The study aims to assess the devices performance compared to a sham control in a randomized, double-blinded design. At least 60 participants will be enrolled across multiple sites to better understand this treatment approach. Participants will be randomly assigned to one of three groups two active ultrasound stimulation groups using different treatment settings and one sham non-active stimulation group. Each participant will receive daily ultrasound stimulation of the spleen for 20 minutes. The initial 12-week period is followed by a one-way crossover where those in the sham group switch to active stimulation, with an additional 12-week follow-up to assess long-term effects. During the study, participants will continue their stable background treatment with conventional synthetic DMARDs. Researchers will monitor changes in disease activity using the DAS28-CRP score from baseline to 12 weeks, comparing active groups to the sham control. Participants will be observed for safety and treatment effects throughout the 28-week study period, including adherence to medication and ultrasound use, with regular assessments and follow-up visits.

Researchers are evaluating the effectiveness of NBI-1065890 compared to a placebo for treating tardive dyskinesia TD in adults. This Phase 2 study focuses on adults aged 18 to 75 with a confirmed diagnosis of TD caused by neuroleptic medication and other related psychiatric conditions such as schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. The study aims to assess the treatments impact on abnormal involuntary movements and overall improvement. Participants will be randomly assigned to receive either NBI-1065890 or a matching placebo, both taken orally. The study uses a parallel design with quadruple masking to compare the effects over an 8-week period. The main measurement is the change in the Abnormal Involuntary Movement Scale AIMS total score from baseline to week 8, along with secondary assessments of clinical global improvement. During the study, participants will undergo blinded video assessments of their movements, and their responses will be evaluated by expert raters. Researchers will monitor the severity of dyskinesia, psychiatric symptoms, and any side effects. The study includes regular visits over the 8-week treatment period, with safety and tolerability closely observed. Total participation lasts at least 8 weeks, concluding with the final evaluation of movement improvement.

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 studying the safety and tolerability of NTR-1011, a fusion protein designed to reduce inflammation by clearing neutrophil extracellular traps, in adults with systemic lupus erythematosus SLE and rheumatoid arthritis RA, as well as in healthy adult volunteers. This Phase 1ab clinical trial aims to determine the highest safe dose of NTR-1011 given either under the skin or intravenously, understand how the body processes the drug, assess immune response to it, and explore early signs of benefit when added to standard treatments. The study has two parts Phase 1a, completed with healthy volunteers receiving single doses of NTR-1011 or placebo via intravenous or subcutaneous routes and Phase 1b, currently recruiting adults with moderate-to-severe SLE or RA who receive five weekly intravenous doses of NTR-1011 alongside their usual care. Dose levels in Phase 1b are adjusted based on safety and response data. No placebo group exists in Phase 1b, and participants are assigned to either the SLE or RA group. Participants undergo physical exams, lab tests, vital sign monitoring, and blood sampling to measure drug levels, immune markers, and antibodies against NTR-1011. Clinical assessments include disease activity scores and patient-reported outcomes specific to SLE and RA. Safety and tolerability are closely monitored throughout treatment and for four weeks after the last dose. The studys findings will help guide future development and dosing of NTR-1011 for autoimmune diseases.

Researchers are evaluating ALTO-300, a drug taken as a capsule once daily in the evening, for adults with moderate to severe major depressive disorder MDD. The study aims to compare the effects of ALTO-300 versus a placebo when added to an antidepressant, focusing on how patient characteristics may influence treatment outcomes. This is a randomized, double-blind trial with a phase 2 design. Participants will be randomly assigned to receive either ALTO-300 or a matching placebo capsule once daily for 42 days during the double-blind period. Those who qualify may then enter an open-label extension period lasting up to 8 weeks, during which all participants receive ALTO-300 once daily. The trial includes careful monitoring throughout both treatment periods. During the study, participants will undergo assessments to measure changes in depression symptoms using the Montgomery-sberg Depression Rating Scale MADRS up to week 6. Safety evaluations include tracking adverse events, heart rate, weight, blood pressure, and suicidality over the course of up to 15 weeks. The total participation duration may extend to 14 weeks, including both blinded and open-label phases, with regular visits and evaluations.