Avondale

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

This research investigates the use of CLN-978, a subcutaneously administered CD19-directed T cell engager, in adults aged 18 to 70 with moderate to severe Systemic Lupus Erythematosus (SLE). The study is an open-label Phase 1b trial exploring the safety and tolerability of this treatment in patients who have not adequately responded to standard therapies such as corticosteroids, antimalarials, immunosuppressants, or biologics. Participants must have active disease with specific autoantibody markers and meet established classification criteria for SLE. Participants receive CLN-978 at specified doses on designated days during the treatment period. The study includes a possible Part B, where eligible patients from Part A who tolerated the treatment without dose-limiting toxicity may receive retreatment at a higher dose or longer schedule after at least 90 days from their last dose. The treatment is delivered subcutaneously, and the study monitors responses over a 48-week period. During the study, participants undergo regular assessments including laboratory tests for blood counts, liver and kidney function, and SLE disease activity scores. Researchers monitor safety and tolerability throughout, with particular attention to adverse events and dose-limiting toxicities. The total participation time spans 48 weeks, during which patients' responses to treatment and overall health status are closely evaluated.

Researchers are evaluating the safety and effectiveness of SPY072 compared to a placebo in adults aged 18 years and older who have moderately to severely active rheumatic diseases. This Phase 2, multi-center, double-blind, placebo-controlled basket study includes participants with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and psoriatic arthritis (PsA) who have not responded adequately to standard treatments. Participants are assigned to receive either SPY072 or a matching placebo. The study includes separate substudies for each condition: RA participants must have active disease despite treatment with conventional or biologic disease-modifying anti-rheumatic drugs; axSpA participants must have active disease despite use of NSAIDs or biologic therapies; PsA participants must have active disease despite NSAIDs, conventional or biologic therapies. Treatments are given during the study period, and participants are monitored for changes in disease activity specific to their condition. During the study, participants undergo assessments including joint counts, disease activity scores, and laboratory tests such as C-reactive protein levels. Researchers measure changes in disease activity scores at 12 or 16 weeks depending on the condition, and evaluate the proportion of PsA participants achieving a clinical response. Safety and efficacy are monitored throughout, with the total participation duration aligned with these outcome measures.

Researchers are evaluating the ability of dapirolizumab pegol (DZP) added to standard care medications to improve moderate to severe systemic lupus erythematosus (SLE) symptoms over the long term. This Phase 3 trial focuses on participants aged 16 and older who have active SLE with specific disease activity and serological markers. The goal is to assess clinical improvement using the British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) at Week 48. Participants will be randomly assigned to receive either dapirolizumab pegol (DZP) or placebo at scheduled times alongside their stable standard of care treatments. Standard medications include antimalarials combined with glucocorticoids and/or immunosuppressants or glucocorticoids and/or immunosuppressants alone if antimalarials are not suitable. The study is double-blind and placebo-controlled, ensuring unbiased comparison between the two groups. Throughout the study, participants will undergo regular assessments to monitor disease activity and treatment safety up to Week 48. Researchers will track responses based on disease activity indices and monitor for any adverse effects. The study includes careful screening and follow-up evaluations to understand the long-term effects of adding DZP to usual care in people with moderately to severely active SLE.

Researchers are evaluating the effectiveness of adding tirzepatide to ixekizumab therapy in adults with active psoriatic arthritis (PsA) who are overweight or obese and have at least one weight-related health issue. This Phase 4 study aims to understand how well this combination works in standard clinical practice over a period of up to 12 months. The focus is on improving physical function and achieving weight loss in this patient group. Participants will receive tirzepatide administered by subcutaneous injection after having been treated with ixekizumab for about three months. The study is open-label and single-arm, meaning all participants will get tirzepatide alongside their ongoing ixekizumab therapy. Treatment will begin within 30 days after deciding to add tirzepatide. No placebo or comparison group is mentioned. During the study, researchers will monitor participants for up to 12 months, measuring their physical functioning using the Health Assessment Questionnaire Disability Index and tracking weight loss. Safety and treatment effects will be assessed through regular evaluations. The study seeks to see how many participants achieve improved function and at least 10% weight loss by the end of the 12-month therapy period.

Researchers are evaluating the effectiveness and safety of sonelokimab compared with placebo in adults with active psoriatic arthritis who have not responded well or could not tolerate anti-tumor necrosis factor alpha (TNFb1) therapy. This Phase 3, randomized, double-blind study also includes risankizumab as an active reference treatment to better understand the benefits and risks of sonelokimab for this condition. Participants will be randomly assigned to one of four groups receiving either sonelokimab at doses of 60 mg or 120 mg, placebo, or risankizumab. The treatments are given by injection under the skin. The study is conducted across multiple centers and compares the response rates after 16 weeks of treatment to evaluate improvement in psoriatic arthritis symptoms. During the trial, participants will undergo joint assessments, blood tests for specific antibodies, and evaluations of skin psoriasis. Researchers will monitor how many participants achieve at least a 50% improvement in arthritis criteria compared to placebo. Safety and side effects will be closely observed throughout the study. The total time involved includes screening, treatment, and follow-up visits to ensure thorough evaluation of both effectiveness and safety.

Researchers are assessing the safety and effectiveness of the VDI Ultra-High Frequency Electrocardiogram (UHF-ECG) System to diagnose ventricular electrical dyssynchrony in adults with bradycardia and heart failure who are scheduled for their first pacemaker implantation. This study compares the UHF-ECG results with the standard 12-lead ECG to evaluate diagnostic accuracy. Participants will undergo electrocardiogram testing using the UHF-ECG device before their pacemaker implantation procedure. The study focuses on patients with specific cardiac conduction issues, including bradycardia with various conduction disturbances or heart failure with left bundle branch block. The UHF-ECG is used as a diagnostic device during the pre-procedure phase. During the study, researchers will collect electrocardiogram data to compare the predictive agreement between the UHF-ECG and the standard ECG. Participants must provide informed consent and, if of childbearing potential, have a negative pregnancy test before the procedure. The study monitors safety and diagnostic performance but does not mention long-term follow-up beyond the pre-procedure evaluation.