UC Davis Health Clinical Studies

A Study of Experimental Tezepelumab for Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

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This study will test the experimental medication tezepelumab (study drug). We hope to learn if it will work and be safe as a medication to treat moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). “Experimental” means that the study drug is currently being tested. To do this, tezepelumab will be compared with placebo. Tezepelumab blocks a chemical that is responsible for inflammation that occurs in the lung. This is a part of how COPD affects the lungs. The placebo will be like tezepelumab but will not contain any active medication. Study drug and placebo will be referred to as “study medication” throughout this text. The study medication will be administered as an injection under your skin every 4 weeks. Tezepelumab is not approved by the FDA, except for use in research studies like this.

Biological study, Phase 2
Any, age 40 to 80 years old

Dose-Range Finding Study of the Effectiveness and Safety of Experimental QBW251 for COPD

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The purpose of this research study is to test the experimental study drug, QBW251. It will be added to the current maximal standard therapy for COPD. We hope to learn if it can improve your lung function compared to standard therapy alone. This drug targets part of the airways to help reduce the thickness of mucus in the lungs. This makes it easier to get out of lung. This study will also investigate the best dose for QBW251. The best dose is where the benefits would outweigh any possible side effects or risks. To perform this comparison, all patients will receive the same standard treatment. It is a combination of all three following medications, sometimes referred to as “triple combination” or “triple therapy: • Long-acting beta-2 agonist (LABA)- this medicine opens the airways in the lungs by relaxing the smooth muscle around the airways. • Long-acting muscarinic receptor antagonist (LAMA). This is similar to the LABA medicine. It opens up the airways in the lungs by relaxing the smooth muscle around the airways. It does so via a different mechanism than LABA. • Inhaled corticosteroid (ICS). This medicine works by reducing inflammation, swelling, and mucus production in the airways.

Drug study, Phase 2
Any, age 40 years or older

Experimental Vedolizumab for Acute Graft Versus Host Disease (aGVHD) in Stem Cell Transplants

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Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a vital therapy. It is used in patients that have various forms of blood cancer. In these patients, the risk of disease recurrence or progression is significant. In this treatment, the patient first receives chemotherapy and/or radiation therapy. This kills blood–forming cells (cells from which all blood cells develop). Then, they receive blood-forming stem cells. These are taken from a genetically similar donor. There can be a complication of graft versus-host disease (GvHD) after this procedure. GvHD occurs when some types of white blood cell (T cells) in the donated cells (the graft) attack your own body cells. This happens because the graft see your body cells (the host) as foreign and attacks them. GvHD can vary in severity depending upon how soon it occurs after transplant. Acute GvHD occurs under 100 days after an allo-HSCT, but can also occur beyond 100 days. Acute graft versus-host disease (aGvHD) most commonly involves the skin, liver or intestines. This study will follow patients for the development of intestinal aGvHD during the first 180 days after allo-HSCT. This research study will test the safety and effectiveness of experimental Vedolizumab. It will be compared to placebo (dummy drug). It is being tested for the prevention of intestinal aGvHD. It will be given to patients undergoing allo-HSCT from an unrelated donor for a hematologic malignancy. These are cancers that affect the blood and/or lymphatic system. This clinical research study will test the anti-inflammatory properties of Vedolizumab. It is given intravenously (IV) directly into your vein using a needle.

Drug study, Phase 3
Any, age 12 years or older

Effectiveness and Safety of Experimental BIIB093 (Glibenclamide) for Severe Cerebral Edema (fluid around brain) After Stroke

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This is a Phase 3 study. This means that experimental BIIB093 (the study drug) has already been tested in previous research studies. It has been tested in a small number of people with large hemispheric infarction (LHI). LHI is a type of stroke. An ischemic stroke occurs when blood flow to parts of the brain is blocked, such as by a blood clot. This can cause damage to the brain. In LHI a large portion of the brain is damaged. People who have LHI can develop swelling of the brain called cerebral edema, which can worsen the symptoms and outcomes of LHI. Previous studies suggested that the study drug was safe, did not cause serious side effects or discomfort, and may reduce brain swelling, disability, and death in subjects with LHI. In this study, we want to investigate the study drug in a larger number of subjects (hundreds) to know more about it. Currently, there are no medications available to specifically reduce brain swelling caused by LHI. In this study, we want to test how well the study drug works to improve functional outcomes (the ability to do normal daily activities, such as walking and getting dressed) in subjects with LHI. This study will also look at the long-term effects of the study drug over time and see how safe the study drug is. What medication is being investigated? The study drug is an experimental drug. “Experimental” means that the study drug is currently being tested and is not approved for sale by the FDA. The study drug is already used in the form of tablets to treat subjects with type 2 diabetes. It is now being investigated as an intravenous infusion (given through a needle into the vein) in subjects with LHI. The study drug is designed to specifically stick to a protein called sulfonylurea receptor 1 (SUR1) and block its activity. SUR1 is found on brain cells and studies have shown that it is involved in the development of cerebral edema after a stroke. By blocking the activity of SUR1, it is hoped that the study drug may reduce brain swelling following LHI. Therefore, it could reduce the damage to the brain. In this study, subjects will receive either the study drug or a placebo. A placebo looks like the study drug but contains no actual medication. You have an equal chance of receiving the study drug or placebo. The study is double-blinded. This means that you and your study doctor will not know which study medication (study drug or placebo) you are receiving. In an emergency, we can find out what study medication you are receiving.

Drug study, Phase 3
Any, age 18 to 85 years old

Safety and Effectiveness of Experimental IMC-C103C With or Without Atezolizumab for Advanced MAGE-A4-positive Cancer

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This study will test increasing doses of the experimetnal study drug, IMC-C103C. It will be given alone and in combination with the drug atezolizumab. The goal is to find the highest dose that is safe to give to people with advanced cancer. This study is the first time IMC-C103C is being tested in people. IMC-C103C is an “experimental medication.” This means that it has not yet been approved by the FDA for use by doctors in treating cancer. IMC-C103C has been developed to treat cancer by activating the body’s own immune system to fight the tumor. IMCC103C has 2 parts. The first part is called a “T cell receptor.” It sticks very tightly to tumor cells that makes the markers “HLAA*02:01” and “MAGE-A4”. The second part is called an “anti-CD3 scFv.” It sticks to a T cell (a type of white blood cell that helps protect your body against disease). IMC-C103C makes the T cell stick to the cancer cell, which then sends a signal to attack the tumor. Atezolizumab is a FDA-approved medication for NSCLC and urothelial cancer. Atezolizumab is an immunotherapy drug (a drug that helps the immune system fight cancer) targeting a protein called PD-L1.

Drug study, Phase [/1/,/ /2/]
Any, age 18 years or older
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