Ulcerative Colitis Research Study
Researchers at Penn State Milton S. Hershey Medical Center are conducting a study to assess the safety and effectiveness of a study drug for the treatment of ulcerative colitis.
Fast Facts
Diagnosed with Ulcerative Colitis
Experiencing UC Symptoms for At Least 3 Months
Compensation
Provided
Conducted in
Hershey, PA
Study Background
Our researchers are assessing the safety and efficacy of 3 dose levels of GS-1427 in adult participants with moderate to severe ulcerative colitis.
Ulcerative colitis is a disorder that causes the digestive system to become inflamed. The results can include uncomfortable or painful symptoms that seriously impact quality of life, as well as a higher risk of other intestinal complications. In this research study, we want to find out if a study drug (GS-1427) is safe and effective at treating ulcerative colitis.
Eligible study participants will be randomly assigned to one of four groups. Three of the groups will take three different doses of the study drug, and one group will take a placebo. The study drug is taken as three tablets once a day. Neither you nor your study doctor will know whether you are taking the placebo.
You may be in the study for at least 12 weeks or up to 76 weeks, depending on how you respond to the treatment. After the first 12 weeks, everyone in the study will have the opportunity to receive the investigational drug. During the study, you may be able to continue the medications you are currently taking, in addition to the investigational drug. However, this excludes certain drugs for ulcerative colitis, which your study doctor will inform you of.
Eventually, we hope that the findings of this study might be useful for treating ulcerative colitis and improving people’s quality of life. Find out if you are eligible today.
Study Background
Our researchers are assessing the safety and efficacy of 3 dose levels of GS-1427 in adult participants with moderate to severe ulcerative colitis.
Ulcerative colitis is a disorder that causes the digestive system to become inflamed. The results can include uncomfortable or painful symptoms that seriously impact quality of life, as well as a higher risk of other intestinal complications. In this research study, we want to find out if a study drug (GS-1427) is safe and effective at treating ulcerative colitis.
Eligible study participants will be randomly assigned to one of four groups. Three of the groups will take three different doses of the study drug, and one group will take a placebo. The study drug is taken as three tablets once a day. Neither you nor your study doctor will know whether you are taking the placebo.
You may be in the study for at least 12 weeks or up to 76 weeks, depending on how you respond to the treatment. After the first 12 weeks, everyone in the study will have the opportunity to receive the investigational drug. During the study, you may be able to continue the medications you are currently taking, in addition to the investigational drug. However, this excludes certain drugs for ulcerative colitis, which your study doctor will inform you of.
Eventually, we hope that the findings of this study might be useful for treating ulcerative colitis and improving people’s quality of life. Find out if you are eligible today.
Additional Information
The purpose of this voluntary research study is to find out if the study drug is safe and works to treat ulcerative colitis.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Diagnosed with ulcerative colitis
- Experiencing ulcerative colitis symptoms for at least 3 months
- Treatments including corticosteroids (steroid hormones), immunomodulators (drugs that change the immune system), or advanced therapy for ulcerative colitis have not worked for you
- Ages 18-75
- Willing to use contraception
- Willing to provide documentation of ulcerative colitis diagnosis
Exclusion Criteria:
- Diagnosis of Crohn’s disease, HIV, or cancer
- History of treatment with Entyvio (vedolizumab)
- History of surgery for ulcerative colitis
- Planned surgery for the next 12-18 months
- Currently pregnant or breastfeeding
First, volunteers will be screened for four weeks to determine eligibility to participate in the study.
Then, if eligible, you will come to the clinic for your study visits. There are about 6 visits including screening and the induction treatment. If you continue on study treatment, there are about seventeen in-person visits.
During the visits, we will check on your health and symptoms. You will have blood and urine tests, heart function tests (electrocardiogram), vital functions (heart rate, blood pressure, breathing rate, temperature), and four endoscopy procedures with biopsies. There is one safety follow up visit four weeks after the drug is discontinued.
At the study treatment visits, the study doctor or staff will provide you with three bottles of study drug. You will be instructed to take one tablet out of each bottle, once per day with water. The study drug will be taken four hours after the last meal, and two hours before the next, at about the same time every day. Depending on your response, you might then continue taking the study drug for a total of 76 weeks.
As a participant, you will be paid $75 per completed visit. You will receive a card and the money will be loaded after each visit. You will also receive a meal card for $20 for the visits occurring at week 2 and week 12.
There is no cost for you to participate in our research study.