DUET-UC: A study of an investigational study medication in participants with Moderately to Severely Active Ulcerative Colitis
The purpose of the DUET study is to evaluate the efficacy and safety of the investigational combination therapy with two investigational study medications in participants with moderately to severely active Ulcerative Colitis.
You may be able to take part in the DUET study if you meet the following criteria:
- Aged 18-65 years
- Have been diagnosed with UC for at least three months
- Have moderately to severely active UC
- Have had an inadequate response or intolerance to an advanced therapy like a biologic medication
Study description/explanation of participation:
The study will last up to 256 weeks. During this time, you will have study visits approximately every 4 weeks.
The study medicine will be administered by injection given subcutaneously (under the skin)
You may receive a placebo (containing no active medication) or the investigational medicine. The chance of being assigned to Placebo is 9%
If you initially receive a placebo in the primary stage of the study and you do not respond you will be switched to the active medication after 24-weeks.
Study participants will receive study-required medical care at no cost
Description of treatment or intervention (mechanism of action):
The investigational combination therapy with two investigational study medications is being tested to see if it will reduce inflammation in the intestines. It will be administered by injection given subcutaneously (under the skin). The study medicine has been approved in several countries for use in other indications. It is not yet approved for UC in any country. Therefore, it can only be used in a research study such as this one.
Come to all study visit appointments
Complete a diary and bring it with you to appointments
Tell the study doctor/staff about any health problems you have during the study
Tell the study staff about any new medicine or drug you take during the study, including over-the-counter drugs.
Tell the study staff about any changes to your ongoing medicines or drugs.
Possible risks and side effects:
Because we are learning about the study medications in combination, all possible side effects and risks related to the study medicine are not known and there is the potential that you may experience side effects. All potential side effects will be discussed by the study staff before you begin the study.
Side effects may range from mild and unpleasant to serious, or even life-threatening. If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be continuously monitored.