Avondale

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are evaluating CLN-978, a subcutaneously administered CD19-directed T cell engager, in adults with moderate to severe Systemic Lupus Erythematosus SLE. This Phase 1b open-label pilot study aims to assess the safety and tolerability of CLN-978 in patients who have active SLE with inadequate response to standard treatments, including corticosteroids, antimalarials, immunosuppressants, or biologics. The study is sponsored by Cullinan Therapeutics Inc. and plans to enroll adults aged 18 to 70 years. Participants will receive CLN-978 administered by subcutaneous injection in two parts Part A involves dose escalation cohorts to determine safe dosing levels, and Part B further evaluates treatments at higher doses or extended schedules for eligible patients from Part A. The treatment duration includes up to 48 weeks of monitoring with specified dosing days. Patients must meet defined laboratory and disease activity criteria to participate, and those in Part B must have had no dose-limiting toxicity or treatment discontinuation in Part A and wait at least 90 days after the last dose. During the study, participants will undergo regular safety and tolerability assessments, including laboratory tests to monitor blood cell counts, kidney and liver function, and immune response markers. Pharmacokinetics, immunogenicity, and pharmacodynamics biomarkers related to treatment effects will also be evaluated over 48 weeks. The study aims to monitor adverse events closely and ensure ongoing assessment of treatment impact on disease activity and patient well-being throughout the trial.

Researchers are evaluating dapirolizumab pegol DZP as an add-on treatment to standard care medications for people with moderate to severe active systemic lupus erythematosus SLE. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess whether DZP can achieve meaningful long-term improvement in disease activity compared to placebo. Participants must have been diagnosed with SLE at least 24 weeks prior and meet specific disease activity and serological criteria. Participants will be randomly assigned to receive either dapirolizumab pegol or placebo throughout the treatment period. Both groups will continue their stable standard of care medications, which may include antimalarials, glucocorticoids, andor immunosuppressants. The study is designed with a parallel group structure and masking to ensure unbiased assessment of efficacy and safety over a treatment period extending up to 48 weeks. During the study, participants will be monitored regularly to assess disease activity using tools such as the British Isles Lupus Assessment Group Disease Activity Index 2004 BILAG 2004 and Systemic Lupus Erythematosus Disease Activity Index 2000 SLEDAI-2K. Researchers will track responses at Week 48 and evaluate additional outcomes like flare prevention, fatigue levels, glucocorticoid dose reduction, and safety events. Follow-up will continue up to Week 54 to monitor adverse events, ensuring comprehensive evaluation of participant health and treatment effects.

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 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 evaluating two experimental drugs, REGN7508 and REGN9933, for people with Peripheral Artery Disease PAD, a condition where blood vessels in the arms and legs become narrowed. The study focuses on individuals who have recently undergone Lower Extremity Revascularization LER, a procedure to improve blood flow in the legs and feet. The goal is to understand how well these drugs prevent serious blood clots compared to rivaroxaban and a placebo, while monitoring side effects and how the drugs affect blood clotting. Participants are randomly assigned to receive either REGN7508, REGN9933, rivaroxaban, or a placebo, with the treatments administered according to the study protocol. The study is designed as a Phase 3, multicenter, randomized trial with multiple groups running in parallel, and participants are followed for up to approximately 42 months. During this time, researchers will monitor drug levels in the blood, check for antibodies against the drugs, and evaluate the effects on blood clotting. Throughout the study, participants will have regular assessments to track the time to serious vascular events such as acute limb ischemia, major amputations, heart attacks, strokes, and cardiovascular death. Safety is closely watched by recording any bleeding events and adverse effects. Laboratory tests will measure blood clotting times and antibody levels up to about 45 months. The total participation duration may last around 3.5 years, with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating the safety and effectiveness of the VDI UHF-ECG System for diagnosing ventricular dyssynchrony in patients with bradycardia and heart failure who are scheduled for pacemaker implantation. This observational study compares the new Ultra High Frequency Electrocardiogram UHF-ECG device with the standard 12-lead ECG to see how well it predicts electrical dyssynchrony in the heart. Participants will undergo both the standard ECG and the UHF-ECG measurements sequentially before their pacemaker procedure. The study focuses on adults with specific heart conditions such as bradycardia with different conduction patterns or heart failure with left bundle branch block. The investigational device is used to gather detailed electrical activity data to improve diagnosis. During the study, researchers will collect and compare ECG data from both devices before the pacemaker implant. Participants will be monitored for predictive agreement between the UHF-ECG and standard ECG results. The study involves informed consent, adherence to study procedures, and a pregnancy test for women of childbearing potential. The trial is expected to continue until May 2027.