Torun

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Researchers are investigating new treatments for rheumatoid arthritis (RA), a condition where current therapies like methotrexate (MTX) may not fully control symptoms for many people. This Phase 2b study evaluates a medicine called tulisokibart to see if it can better reduce RA symptoms in individuals already taking MTX. The trial aims to determine if one or more doses of tulisokibart work better than a placebo, which looks like the medicine but contains no active drug. The study includes a 12-week period where participants receive either tulisokibart or a placebo by subcutaneous injection while continuing their MTX treatment, which can be given by injection or orally. Following this, there is a long-term extension lasting 116 weeks, composed of a 44-week main extension and a 72-week optional extension, to further assess the medication's effects and safety over time. Participants will undergo assessments to measure treatment response, including the American College of Rheumatology 20% response criteria at week 12 to gauge symptom improvement. Throughout the study, researchers will monitor for safety and effectiveness, with evaluations extending through the long-term extension periods, totaling over two years of participation.

Researchers are evaluating the long-term safety and effectiveness of TAK-279 (also called Zasocitinib) in adults with moderately to severely active Crohn's Disease or Ulcerative Colitis, which are serious inflammatory bowel diseases causing pain and swelling in the intestines. This study is an extension of two earlier phase 2 trials where participants who responded to TAK-279 may continue to receive treatment. The goal is to understand how well TAK-279 controls bowel inflammation and symptoms when used for up to two years. Participants will receive oral Zasocitinib capsules for up to 108 weeks. During this time, they will attend 11 visits at their study clinic for treatment and monitoring. This open-label extension study focuses on long-term safety, tolerability, and sustained response in those who showed improvement in the initial parent trials. Throughout the study, researchers will track the number of participants experiencing treatment-related side effects, significant changes in vital signs, lab tests, and ECG results. Participants' symptoms and inflammation will be regularly assessed to monitor TAK-279's ongoing effects. The study includes safety monitoring from the start of treatment to week 112, with careful attention to any adverse events or important changes in health measurements.

Researchers are evaluating ELVN-001, a new drug, in adults with chronic myeloid leukemia (CML), including those with or without a specific T315I mutation. This early phase 1a/1b study aims to find the best dose of ELVN-001 for future studies by assessing its safety, tolerability, and how the body processes the drug. The study also looks at changes in a key leukemia marker called BCR-ABL1 to gather initial evidence of the drug's effect on CML. Participants will receive ELVN-001 orally once or twice daily. The trial includes a dose escalation period to identify recommended doses for further research. This first-in-human study will monitor patients closely to understand the safety profile and pharmacokinetics of ELVN-001. The drug is being tested in patients who have relapsed, are resistant, or cannot tolerate other tyrosine kinase inhibitors (TKIs). Throughout the study, participants will be monitored for adverse events, dose-limiting toxicities, and any significant lab or heart test abnormalities up to 28 days in phase 1a and for up to 3 years in phase 1b. Researchers will assess safety, tolerability, and leukemia markers regularly. The total duration of monitoring allows for a thorough evaluation of ELVN-001's effects and safety in adults with chronic phase CML.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating an investigational drug called linvoseltamab in adults at moderate risk of developing multiple myeloma. This includes patients with precancerous conditions known as High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The study aims to understand how well linvoseltamab can eliminate abnormal plasma cells and improve laboratory signs related to these conditions. It is a Phase 2 dose-ranging and interception study focused on these specific patient groups. Participants receive linvoseltamab as directed by the study protocol. The treatment schedule and dosing details are determined per protocol to assess the drug's effects and safety. The study does not mention comparator groups, focusing solely on evaluating linvoseltamab. The study includes a safety observation period lasting 35 days to monitor adverse events and a long-term follow-up of up to 5.5 years to assess the achievement of complete response. During the study, participants are regularly monitored for side effects and treatment-emergent adverse events. Researchers measure how often these events occur and their severity during the 35-day safety period. They also evaluate whether participants achieve a complete response, as determined by the investigator, over up to 5.5 years. Blood tests and laboratory evaluations are conducted to track drug levels and immune responses, including antibody formation against linvoseltamab. The study involves ongoing safety and effectiveness assessments throughout the participation period.

Researchers are evaluating how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.