A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj gren s Syndrome With Moderate-to-Severe Symptom State
The Oasiz-303 Study is evaluating the safety and effectiveness of an investigational medicine in people living with Sjögren’s. This investigationalmedicine works differently from other medicines for Sjögren’s. While available medicines may help to manage symptoms, this investigational medicine is being evaluated to see if it may have an effect on disease progression. The research study will last up to 60 weeks (14 months) and will require up to 16 visits to the study site. After completing the Study Treatment Period, you may be eligible to join an extension study, during which all participants will receive the investigational medicine for a period of time.
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sj gren s Syndrome With Moderate-to-severe Systemic Disease Activity
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of a study drug called dazodalibep (also known as VIB4920) in participants with Sjögren's syndrome (SS). Dazodalibep is being developed as a potential treatment for SS, which causes the body’s immune system to attack itself. The immune system helps the body fight off infections. When the body's immune system attacks itself, this can cause what is called an “autoimmune disease”. Dazodalibep is designed to target the immune system cells responsible for these attacks. Dazodalibep is an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for use outside of a research study.
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sj gren s Syndrome (POETYK-SjS-1)
This is the first time deucravacitinib is being studied in people with Sjogren’s Syndrome. By doing this study, researchers hope to learn more about whether deucravacitinib can help in the treatment of Sjogren’s Syndrome (SjS) and how safe it is to use in participants with active SjS. Deucravacitinib is an experimental drug, which means its safety and effectiveness have not been established and it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of SjS. Placebo for deucravacitinib treatment consists of a pill that looks like the study drug but does not contain any active study drug.
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POETYK-SLE-2)
The 52-week double-blinded study is divided into 3 separate periods that will take about 60 weeks to complete:• Screening Period (4 weeks), • Treatment Period (52 weeks), and • Safety Follow-Up (4 weeks). • The Treatment Period is called a “Double-Blinded” or “Blinded” Treatment Period because neither you nor your study team will know whether you are getting deucravacitinib or placebo. There is a 50% chance of being on deucravacitinib and a 50% chance of being on placebo during this 52-week Treatment Period.Participants who complete the Treatment Period (either on deucravacitinib or placebo), may be able to enter into an optional Long-Term Extension (LTE) Period of up to 2 years (104 weeks). -
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (POTEYK-SLE-1)
This is a Phase 3, randomized, parallel-arm, double-blind, PBO-controlled, multicenter 52-week clinical trial to evaluate the efficacy and safety of deucravacitinib in adult participants with active SLE while receiving stable background standard of care treatment. There is an optional 104-week open-label long-term-extension (LTE) period.
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) - ALXN1210-IgAN-320
We are doing this study to learn more about the study drug, called ravulizumab, which can also be referred to as ALXN1210, and also to better understand the studied disease and associated health problems. Ravulizumab has already been approved in various countries as a safe and effective therapy for four other conditions under the brand name Ultomiris®, but we now want to explore this medication with IgAN.
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event ACCLAIM-Lp(a)
This study is being done to learn more about the safety and effectiveness of the drug Lepodisiran (LY3819469) in lowering Lp(a) levels and reducing cardiovascular events in people with cardiovascular disease or who are at risk for a first cardiovascular (CV) event and provide additional evidence for the potential clinical benefits of Lepodisiran. Lp(a) is a molecule in the blood that carries cholesterol, and is a known risk factor for cardiovascular disease (CVD). High levels of Lp(a) increase the risk of cardiovascular events such as heart attacks, stroke and aortic stenosis. Unlike other risk factors, for example blood cholesterol levels, which can be influenced by diet, exercise, or obesity, Lp(a) levels are inherited and stay relatively stable from childhood. Until recently, the role of Lp(a) was not well understood and therefore it was not routinely tested for in patients.
A Phase 3 Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event ACCLAIM-Lp(a)
The purpose of this study is to investigate the effect of lepodisiran on the reduction of major adverse cardiovascular events (MACE) in adults with elevated Lp(a) and established atherosclerotic cardiovascular disease (ASCVD) or who are at risk for a first cardiovascular (CV) event and provide additional evidence for the potential clinical benefits of Lepodisiran.
A Phase 3 Randomized Multicenter Double-Blind Placebo-Controlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)
The purpose of this research study is to see if an investigational drug, acoramidis (AG10), is safe and effective in preventing or delaying symptoms of a disease called Transthyretin Amyloidosis (ATTR).
A Phase 3 randomized open-label multicenter controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician s choice chemotherapy compared to trastuzumab in combination with physician s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on or are intolerant to previous trastuzumab deruxtecan treatment
This study tests a new treatment called zanidatamab against a standard treatment called trastuzumab. Both treatments will be given with chemotherapy chosen by the doctor for patients with metastatic HER2-positive breast cancer who have not done well on or cannot tolerate a previous treatment called T-DXd. To join the study, patients need to have had at least two lines of HER2-directed therapies before. Patients will be checked for HER2-positive status before being enrolled, and randomization will happen once they meet all the study criteria. Patients will be assigned randomly to one of the two treatments, with groups based on their past treatments and where they live. They will receive their treatment in 21-day cycles until their disease gets worse, they decide to leave the study, or other reasons to stop occur. The study will keep a close watch on how effective the treatments are, with patients getting regular scans to check their health.