Alcobendas

This trial evaluates the effectiveness of dotinurad compared with allopurinol in lowering serum uric acid levels in adults with gout-related hyperuricemia. The study focuses on reducing uric acid to below 6.0 mgdL after 24 weeks of treatment, addressing a common complication in gout patients. It is a phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years with a history of gout. Participants are randomly assigned to one of three groups one group continues allopurinol at their existing dose once daily through week 64 the second group receives dotinurad starting at 1 mg once daily for the first 4 weeks, then 2 mg once daily through week 64 the third group begins with 1 mg daily for 4 weeks, increases to 2 mg daily for 8 weeks, then continues 4 mg daily through week 64. All treatments are administered orally as over-encapsulated tablets. Throughout the study, participants undergo regular monitoring of serum uric acid levels and gout flares from baseline up to week 68. Assessments include measuring the percentage of participants achieving target uric acid levels at various points, gout flare rates, and treatment-emergent adverse events. The study also evaluates safety and tolerability over the course of the treatment period, which lasts up to approximately 68 weeks including follow-up.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting joints and skin in people with psoriasis. This trial evaluates how well the drug zasocitinib TAK-279 works in adults with active PsA, focusing on participants past experiences with certain treatments. The study is a phase 3 clinical trial designed to assess treatment effectiveness and safety. Participants will be randomly assigned to one of three groups one receiving zasocitinib Dose A tablets once daily for up to 52 weeks, another receiving zasocitinib Dose B tablets once daily for up to 52 weeks, and a third group receiving a placebo once daily for 16 weeks followed by either Dose A or Dose B of zasocitinib once daily through week 52. This design allows comparison of doses and placebo effects during the early treatment period. During the study, participants will undergo regular assessments including joint counts and skin evaluations to monitor disease activity and response to treatment. Researchers will measure the percentage of participants achieving specific response criteria such as the American College of Rheumatology 20 ACR20 response at week 16. Safety and other health outcomes like fatigue, physical function, and quality of life will also be tracked. Total participation can last up to 60 weeks, including treatment and follow-up periods.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

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.

Femoroacetabular impingement is a common cause of pain at the front of the hip, particularly affecting young and middle-aged adults. This condition results from abnormal contact between the upper thigh bone and the hip socket, which can damage soft tissues and cause discomfort. Researchers are studying whether adding a minimally invasive treatment called ultrasound-guided percutaneous electrolysis to a home exercise program helps reduce hip pain and improve function better than exercises alone. Participants will be randomly divided into two groups. One group will receive two sessions of ultrasound-guided percutaneous electrolysis targeting specific hip tissues, combined with a home exercise program focusing on hip mobility, strength, and stability, performed 3 to 4 times per week for four weeks. The other group will do the same exercise program without the electrolysis treatment. The electrolysis sessions use a fine needle and a small electrical current applied under ultrasound guidance. Participants will be evaluated at the start, after one week, and after four weeks. Researchers will measure hip pain during certain tests, hip movement range, and self-reported hip function. Safety will be monitored by recording any side effects. This five-week pilot study aims to provide early evidence on whether adding electrolysis to exercise therapy might be a safe and helpful non-surgical option for hip pain due to femoroacetabular impingement.