Do you still have symptoms of ulcerative colitis, even though you’ve received treatment for your condition?
What is Ulcerative Colitis?
Ulcerative colitis (UC) is a chronic, or long-lasting disease that causes inflammation of the large intestine, and sores, called ulcers, in its inner lining. The affected part of the large intestine includes the colon and the rectum, which is the lower end of the colon.
Usually, the large intestine absorbs water from stools and changes them from a liquid to a solid. In ulcerative colitis, the inflammation causes a reduction in the lining of the colon, leading to symptoms which include:
- bleeding in your intestine
- production of pus
- abdominal (stomach) discomfort
Why is the Hickory Study being conducted?
While there is no cure for ulcerative colitis, there are medications that may help reduce symptoms of the disease. The aim of medical treatment for patients with ulcerative colitis is to induce and maintain remission of the symptoms for long periods of time. Many people with moderately to severely active ulcerative colitis may need to take medication in an injectable form. Unfortunately, the current standard medications may not work, may lose their effectiveness over time, and may have side effects. It is for this reason we want to investigate new treatment options for people with moderately to severely active ulcerative colitis.
What is the Hickory Study?
The Hickory Study will look at the safety and effectiveness of an investigational, once-a-month injectable medication for people with moderately to severely active ulcerative colitis. The aim of the study is to look at the effect of the investigational medication in patients who are still experiencing symptoms of ulcerative colitis despite previously being treated with a class of injectable drugs called tumor necrosis factor (TNF) inhibitors, such as Remicade (infliximab), Humira (adalimumab), and Simponi (golimumab).
The Hickory Study will compare the investigational medication with placebo (which looks the same as the investigational medication but contains no active medication). Parts of this study are blinded, which means that neither you nor the study doctor will know whether you are taking the investigational medication or the placebo. Your participation will last for up to 82 weeks and will involve regular study center visits and telephone calls.
At the end of your participation in the study, you may be eligible to receive study medication as part of a separate extension study. If you decide to stop taking study medication, you will have a follow-up visit at the study center 12 weeks later. We will also ask if we can contact you by telephone every 6 months, for up to 2 years, for additional safety monitoring as part of your separate study.