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About Clinical Research

Clinical studies are done to test investigational medications for diseases and conditions. Studies help determine if investigational medications are safe to use and work to improve the health of people. Before any medication can be approved and made available to the general public, it has to go through several phases of clinical research.

Why do people participate in studies?

People participate in clinical studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help them and others in the future.

Are clinical studies safe?

Clinical studies follow a specific set of standards and are closely regulated to ensure the safety of all participants. Safety precautions are put in place to protect people who participate in clinical studies. In addition, studies follow a written plan that is called a protocol. The protocol is designed to make sure all study procedures are conducted correctly and safely.

What if I have questions during the study?

You can ask questions of the study team at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.

Can I leave the study once it has started?

Study participation is completely voluntary, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.

Can I see other doctors during the study?

You can visit any doctor to meet your needs during the study. Please let the study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit.

About Ulcerative Colitis

Ulcerative Colitis (UC) is a chronic disease of the large intestine, which is also known as the colon. If you have UC, the lining of your colon becomes inflamed and forms ulcers. UC often causes pain, bleeding, and loose bowel movements.

UC is a type of irritable bowel disease (IBD). The number of patients diagnosed with IBD has increased significantly across the past 50 years, with 1.6 million people in the United States alone affected by IBD. The incidence of IBDs, including UC, is highest among people between the ages of 20 and 40, often affecting individuals during their healthiest and most productive years of life.

Typical symptoms of UC include:

  • Loose and urgent bowel movements
  • Frequent diarrhea
  • Bloody stool
  • Stomach pain

More research is needed to better understand what causes the disease and how to best treat it.

About the Study

The OASIS clinical study is for people with Ulcerative Colitis (UC). The purpose of the study is to learn if an investigational medication may safely and effectively reduce the inflammation of the gut in patients with moderately to severely active UC.

Who Can Participate

You may be able to join the study if you:

  • Are 18 to 80 years old
  • Have been diagnosed with UC for at least 6 months
  • Have failed to respond to at least 1 medication to treat UC

About the investigational medication

APD334 is being evaluated in the OASIS clinical study to treat auto-immune diseases, including UC. APD334 is considered investigational because it is not approved by health authorities, including the U.S. Food and Drug Administration (FDA) for the treatment of UC.

What will happen during the study?

If you qualify for and decide to participate in the OASIS clinical study, you will be required to:

  • Attend between 7 and 10 study visits
  • Take the study medication once daily
  • Record your UC symptoms in an electronic diary
  • Receive an endoscopy and biopsy before you begin the study and after the study ends
  • Provide urine, stool, and blood samples
  • Wear a device (Holter monitor) for 48 hours to track your heart’s electrical activity
  • Follow all directions from the study staff
  • Have a chance to continue onto a 40-week extension study with access to the investigational medication