Howell

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.

Researchers are evaluating the safety and effectiveness of the Cordella Pulmonary Artery Sensor System in adults with New York Heart Association NYHA Class II and III heart failure. This multi-center, open-label, randomized controlled trial aims to assess how well this device helps manage heart failure by providing daily pulmonary artery pressure PAP measurements to clinicians and patients. The study includes multiple groups to compare different management strategies and patient self-management approaches. Participants will receive the Cordella Sensor device, which measures and transmits daily PAP data along with other vital signs such as blood pressure, weight, heart rate, and oxygen saturation. Clinicians will manage patients heart failure therapy based on these data using guideline-directed medical therapy. Some participants will follow a clinician-directed patient self-management plan involving daily PAP measurement and medication adjustments. The trial includes several study arms for both NYHA Class II and III cohorts, with some participants potentially crossing over between groups after a period. During the study, participants will take daily measurements using the Cordella system and attend scheduled follow-up visits. Researchers will monitor heart failure events, hospitalizations, mortality, device safety, and pressure sensor performance over months to years. The primary outcomes include heart failure events or cardiovascular death at 6 to 24 months, and safety outcomes related to device complications and sensor failure. Secondary outcomes cover hospitalization rates, medication changes, quality of life, functional status, and economic analyses. Participants are expected to comply with device use and follow-up visits throughout the trial duration, which may extend up to five years.