
What is a clinical study?
A clinical research study is a medical study that helps to answer important questions about an investigational medication or drug, such as:
- Does it work?
- How safe is it?
- What are the side effects?
- Does it affect people differently based on their age, sex, gender, race, and ethnicity?
Clinical research studies test possible new medications. The results of these studies are crucial to whether medications receive approval to be given to patients. An Institutional Review Board (IRB)/Ethics Committee (EC) protects the rights, safety, and well-being of study participants. An IRB/EC has reviewed this study.
About the HORIZON Study
The HORIZON Study is looking to find out more about an investigational study drug for adults with moderate to severe ulcerative colitis (UC). This study will specifically enroll adults who have tried at least 1 previous therapy for UC that did not work. The investigational study drug is designed to block 2 proteins in the body that contribute to the inflammation that is thought to lead to people getting UC. The purpose of this study is to compare the safety and effectiveness of the investigational study drug to an approved drug for the treatment of UC. Participants will not know if they receive the investigational study drug or the approved drug.
HORIZON Study quick facts
The study will last about 1 year and 4 months
Approximately 200 adults will take part in the study
Tell me more about the study treatment
The first time participants receive the assigned study treatment (either the investigational study drug or the approved drug), they will have the following:
1 intravenous infusion (a slow drip into a vein), and 2 subcutaneous (under the skin) injections. After this, the study treatment will be given only as a subcutaneous injection.
Participants will continue to receive the study treatment at study center visits, or a supply will be given to take
at home by self-injection.
Other factors to consider
A group of doctors, nurses, and other medical staff (the study staff) will:
- explain the possible risks and benefits of the study
- carefully monitor the health of participants
- provide the study treatment and study-related tests at no cost. Participants will not be paid to take part in this study. They may be paid back (reimbursed) for reasonable time and travel costs.
Taking part in a clinical study is an important decision. Please ask any questions you have before deciding whether to take part.
Who can take part?
You may be able to take part if you:
- are 18 years of age or older
- have a confirmed diagnosis of moderate to severe UC for at least 3 months
- have tried at least 1 previous therapy for UC that did not work
- have not previously received adalimumab
How do I get more information?
Study participation is voluntary. If you contact us, you do not have to take part in the study.
If you meet the listed eligibility criteria and would like to learn more about the HORIZON Ulcerative Colitis Clinical Trial, please call (318) 525-3233 to speak with the clinical research coordinator.