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Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda group will receive 200 mg every 3 weeks for 8 cycles 24 weeks, then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

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.

Researchers are evaluating the efficacy of dotinurad compared with allopurinol in lowering serum uric acid sUA levels in adults with tophaceous gout. This Phase 3 trial focuses on adult participants aged 18 to 75 years who have measurable tophi and a diagnosis of gout for at least one year. The study aims to assess how well dotinurad reduces sUA levels at Week 24 compared to allopurinol, an established treatment for this condition. Participants are randomly assigned to one of two treatment groups. One group will stop their current allopurinol and continue with study-supplied allopurinol once daily through Week 76. The other group will discontinue allopurinol and start dotinurad at 1 mg daily for the first 4 weeks, then increase to 2 mg daily for the next 8 weeks, and finally 4 mg daily thereafter until Week 76. Both treatments are given as oral tablets, and participants are closely monitored throughout the study. During the study, participants will undergo various assessments including blood tests to measure serum uric acid levels at multiple time points, evaluation of tophi response, and tracking of gout flare frequency and severity. Safety monitoring will include recording any adverse events and serious side effects up to Week 80. The main outcome measures focus on the percentage of participants achieving target sUA levels at Week 24 and clinical responses in tophi at Week 76, with ongoing evaluations up to Week 80 to assess longer-term effects and safety.

Researchers are evaluating the safety and effectiveness of rapcabtagene autoleucel in adults with active, treatment-resistant systemic lupus erythematosus SLE or lupus nephritis LN. This phase 2, open-label study focuses on patients who have not responded adequately to at least two prior therapies and meet specific criteria for disease activity and antibody presence. Participants will receive a single infusion of rapcabtagene autoleucel after lymphodepletion. The study includes monitoring at weeks 24 and 52 to assess how well the treatment works. This approach aims to understand if this biological therapy can improve lupus symptoms and kidney involvement. During the trial, participants will undergo regular evaluations including disease activity scores, kidney response, flare frequency, corticosteroid use, serological status, and fatigue levels. Researchers will closely monitor safety and long-term effects up to week 76, with follow-up visits to assess treatment durability and participant well-being.

Researchers are evaluating etrasimod for treating adolescents aged 12 to under 18 years with moderately to severely active ulcerative colitis. This Phase 2 study aims to determine the safety, effectiveness, and how the drug is processed in the body over a 52-week treatment period. Participants who complete this treatment may continue in a long-term extension for up to 4 additional years, totaling 5 years after enrollment. Participants will take etrasimod tablets or granules by mouth once daily for up to 52 weeks. After this period, those who complete the treatment can join an optional long-term extension phase lasting up to 4 years. The study does not include a placebo group and involves a single treatment arm. During the study, participants will be monitored through regular assessments including clinical remission measured by the Modified Mayo Score at week 52. Blood samples will be taken at various times to measure drug levels. Other outcomes include endoscopic improvement, symptomatic remission, and safety evaluations through adverse event tracking. The total participation could last up to 5 years for those continuing in the extension phase.

Researchers are evaluating the effectiveness, safety, and tolerability of a vaccine designed to reduce Clostridioides difficile C. difficile infections in adults aged 65 years and older. This phase 3 study compares the vaccine to a placebo in a group of older adults who have recent or planned contact with healthcare systems or recent antibiotic use. The purpose is to understand how well the vaccine works to prevent infections and to monitor any side effects or reactions. Participants will receive either the C. difficile vaccine or a placebo shot injected into the upper arm muscle. The study is randomized, double-blinded, and placebo-controlled. The vaccination period includes two doses and participants will be monitored for up to about three and a half years. Follow-up includes three planned clinical visits and three phone visits initially, then yearly clinic visits until the study ends. Participants are asked to report and save stool samples if they experience three or more loose stools in 24 hours to check for possible infection. During the study, researchers will track local and systemic reactions to the vaccine within seven days after each shot, adverse events up to one month after each vaccination, and serious adverse events for up to 18 months after the last dose. The main measurement is the occurrence of medically attended primary C. difficile infections from two weeks after the second vaccination through the surveillance period. Safety monitoring and annual visits will continue until the study is completed, which could be sooner or later depending on infection rates.

Researchers are conducting a long-term observational study called ATHN Transcends to better understand non-cancerous blood disorders. This study follows participants with various hematologic conditions, including hemophilia, von Willebrand Disease, congenital platelet disorders, rare bleeding disorders, thrombosis, and other related conditions. The aim is to collect uniform and high-quality data on the safety, effectiveness, and treatment practices of new and existing therapies over many years, addressing gaps beyond initial clinical trials and real-world treatment outcomes. Participants are assigned to specific cohorts based on their diagnosis, such as Hemophilia, Congenital Platelet Disorders, and others. Within these cohorts, there are multiple study arms and modules focusing on different therapies or disease aspects, including gene therapy outcomes and product-specific data collection. Data is gathered through scheduled assessments at enrollment, every six months, annually, and as needed, with follow-up planned for a minimum of 15 years. The study also includes a biorepository for collecting biological samples to support current and future research. Throughout the study, participants provide information during regular visits, and data is collected about their medication use, bleeding events, and treatment effectiveness. Researchers monitor safety and treatment outcomes continuously to better understand long-term effects. The study involves comprehensive evaluations but does not involve administering treatments instead, it observes participants receiving usual care. Participants may remain in the study for many years, contributing to a valuable resource that helps improve understanding of blood disorders and their management.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

This trial focuses on adults with primary IgA nephropathy IgAN who have already completed 9 months of treatment with TARPEYO4 delayed-release budesonide capsules at 16 mg once daily in regular clinical practice. The study aims to determine if continuing TARPEYO4 treatment provides further benefits in reducing proteinuria and protecting kidney function over a longer period. This is a phase 4, open-label study sponsored by Calliditas Therapeutics AB. Participants will undergo an extended treatment regimen lasting about 15 months, starting with 6 months of TARPEYO4 16 mg once daily, followed by 9 months of TARPEYO4 8 mg once daily. After this, there will be a 3-month follow-up period, including a 2-week tapering phase with TARPEYO4 4 mg once daily. The goal is to maintain or improve treatment effects while reducing dosage gradually. During the study, participants will have urine tests, blood samples, and physical exams at regular intervals to monitor kidney function and protein levels. Researchers will measure the urine protein to creatinine ratio UPCR and estimated glomerular filtration rate eGFR at various points, assessing safety by tracking adverse events over approximately 19 months. The study includes thorough follow-up to evaluate the ongoing impact of extended TARPEYO4 use.