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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 the effect and safety of different doses of the medicine NNC0662-0419 in adults living with type 2 diabetes. This phase 2 clinical trial compares NNC0662-0419 with placebo and an approved diabetes medication called semaglutide. The goal is to find out if NNC0662-0419 is effective and safe for lowering blood sugar in people with type 2 diabetes. Participants will receive one of three treatments NNC0662-0419, semaglutide, or placebo. All treatments are given once weekly by injection under the skin. NNC0662-0419 will be given in increasing doses during the study. Semaglutide and placebo will also be given by weekly injections to match the other groups. Treatment assignment is random and participants will not know which treatment they receive. During the study, participants will be monitored regularly for changes in blood sugar levels measured by glycated hemoglobin HbA1c at weeks 16, 28, and 40. Additional assessments include body weight, fasting glucose, cholesterol levels, kidney function, waist size, inflammatory markers, and safety through adverse event tracking. The study lasts about 40 weeks of treatment with follow-up to week 44 to evaluate effects and safety.

Researchers are evaluating nipocalimab compared to placebo in adults with moderate to severe Systemic Lupus Erythematosus SLE, a chronic condition where the immune system attacks healthy tissues causing inflammation in various organs. This Phase 3 study aims to measure how well nipocalimab works using the SLE Responder Index SRI-4 response at Week 52 as the primary outcome. Participants will be randomly assigned to receive either nipocalimab or placebo along with standard care treatments during a 52-week double-blind period. After Week 52, eligible participants from both groups can join an open-label extension where they will receive nipocalimab until Week 156 or until the treatment is stopped. Throughout the study, participants will have regular assessments including physical exams, medical history reviews, vital signs, ECGs, and disease activity scoring. Researchers will track responses such as disease activity, joint pain, fatigue, and flare status at Week 52. Safety monitoring will continue during the extension period, with total participation lasting up to about three years.

Psoriatic arthritis PsA is a long-lasting inflammatory condition affecting the joints and skin in people with psoriasis. This study aims to understand how well the drug zasocitinib TAK-279 works in adults with active PsA who have never been treated with biologic disease-modifying antirheumatic drugs. Participants will be involved in this Phase 3 trial to evaluate the drugs effects and safety. Participants will be randomly assigned to one of several groups receiving different treatments. Some will take zasocitinib Dose A or Dose B tablets once daily for up to 52 weeks. Others will receive an active comparator capsule twice daily for up to 52 weeks. A placebo group will take placebo once daily for 16 weeks, then switch to zasocitinib Dose A or B from Week 16 to Week 52. This design allows comparison between the new drug, an active treatment, and placebo. During the study, participants will have regular visits and assessments to monitor their joint and skin symptoms. Researchers will measure responses using criteria like the American College of Rheumatology 20 ACR20 response at Week 16, among other disease activity and quality of life assessments. The study duration for each participant can last up to 60 weeks, including treatment and follow-up to evaluate the drugs impact and safety.

Researchers are evaluating the effectiveness of apremilast compared with a placebo in treating juvenile psoriatic arthritis JPsA in children aged 5 to less than 18 years. This phase 3 study aims to understand how well apremilast works in this pediatric population with active disease who have not responded adequately to other treatments. Participants will be randomly assigned to receive either apremilast or a matching placebo orally during a 16-week double-blind treatment phase. After this, all participants will continue on apremilast for an additional 36 weeks in an active treatment phase. The study is designed to compare responses between the apremilast and placebo groups during the initial phase and then monitor all participants while on apremilast. Throughout the study, participants will be assessed for improvements in arthritis symptoms using criteria such as the American College of Rheumatology Pediatric ACR Pedi response at week 16. Researchers will also monitor pain levels, joint function, inflammation markers, and overall well-being. Safety will be evaluated by tracking adverse events and changes in growth and development parameters over the 56-week period.

Researchers are studying the effect of Ofatumumab treatment on people with Relapsing Multiple Sclerosis RMS in Portugal. This observational study compares patients who started Ofatumumab within 3 years of their RMS diagnosis to those who began treatment more than 3 years after diagnosis. The goal is to understand how effective Ofatumumab is in routine medical care settings. The study includes two groups one with early treatment initiation and one with later treatment initiation. Patients either started Ofatumumab up to 12 months before joining the study or start it at the time of inclusion. The study collects data over a period of up to 24 months across three main visits. Additional visits may occur if there is worsening of disability scores to confirm changes. Participants will complete questionnaires and assessments including the Multiple Sclerosis Impact Scale and Fatigue Symptoms Questionnaire at the start and during follow-up visits. Researchers will monitor disease activity using the No Evidence of Disease Activity NEDA-3 measure between 12 and 24 months. Treatment satisfaction and discontinuation rates will also be tracked. The study lasts up to two years per participant, with regular monitoring of disease status and treatment outcomes.

Researchers are evaluating the efficacy, safety, and tolerability of folate-based liposomes encapsulating methotrexate FBL-MTX administered by subcutaneous injection in patients with moderate-to-severe active rheumatoid arthritis RA. This Phase IIa proof-of-concept study focuses on patients who are either new to disease-modifying antirheumatic drugs DMARD-nave or have had an inadequate response or intolerance to oral methotrexate. The study aims to explore whether the subcutaneous route offers a patient-friendly treatment with comparable efficacy. The study treatment involves administering FBL-MTX by subcutaneous injection with dosing adjusted based on clinical response. DMARD-nave patients start with a 1 mg dose, which can be increased every four weeks over 12 weeks up to a maximum of 2.5 mg every two weeks. Patients with an inadequate response or intolerance to oral methotrexate start at 2.5 mg, with similar dose titration. The treatment period includes eight visits spaced two weeks apart. Participants will be screened within 28 days before treatment to confirm eligibility. During the study, assessments will include disease activity scores such as DAS28-CRP, clinical response criteria ACR20, ACR50, ACR70, and quality-of-life questionnaires over 14 weeks. Safety monitoring includes tracking adverse events and laboratory tests. The total study duration for each participant spans from screening up to week 14 of treatment evaluation.

Researchers are evaluating whether the drug zilebesiran can reduce major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, and heart failure episodes in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to gather sufficient clinical outcome events to determine the drugs impact compared to placebo. Participants will receive either 300 mg of zilebesiran or a placebo through subcutaneous injection every six months, in addition to their usual antihypertensive medications that include at least two standard drugs, one being a diuretic. The study treatments are given as add-on therapy alongside the participants existing blood pressure management. The study will continue until enough cardiovascular events have occurred to assess the primary outcome. During the study, participants will be monitored for up to approximately five years. Researchers will track the time to the first occurrence of a combined endpoint including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events requiring hospitalization or urgent visits. Blood pressure changes will also be measured at six months. Safety and efficacy will be closely followed through regular visits and assessments. The long follow-up period allows for thorough evaluation of cardiovascular outcomes and treatment effects.