CONCLUDE Study

The aim of the CONCLUDE Study is to assess the safety and effectiveness of an investigational medicine in people with moderate to severe ulcerative colitis.

The investigational medicine, called cobitolimod, will be compared with a placebo. A placebo looks exactly like the investigational medicine but contains no active medication.

The results will help determine whether the investigational medication can be approved for the treatment of ulcerative colitis. It is in the last phase of the drug development called a Phase 3 study and several studies have previously been performed with cobitolmod.

You may be able to take part in this study if you:

  • Are 18 years of age or over

  • Have been diagnosed with ulcerative colitis for at least 3 months

  • Have a moderate to severe form of the disease

  • Have not responded to previous treatments

What is the CONCLUDE Study?

The CONCLUDE Study is divided into 2 phases.

Phase 1

In the first phase, called the Induction study, your participation including the screening visits will last up to 10 weeks during which you will be expected to attend the study center 5 times. Extra visits may be required if necessary, which will be determined by the study doctor.

The first phase consists of 3 parts:

Phase 1, Part 1: Screening

During the screening period your eligibility to participate will be assessed. If you are eligible, you will receive a phone call from a member of the study team, who will ask you a few questions about your health and determine whether you are still willing to participate in the study. You will then be scheduled for a study treatment visit.

Phase 1, Part 2: Study Treatment

You will receive the investigational medication/placebo at two separate visits. You will also undergo further tests.

Phase 1, Part 3: Assessment

When the study treatment ends, you will be asked to return to the study center once to undergo further and final tests.

Phase 2

The second phase is called the Maintenance study. Here your participation will last up to 46 weeks during which you will be expected to attend the study center 4 times and meet via telephone 3 times. A final visit after 46 weeks will determine if the treatment worked. You will have a 1 of 2 chance to receive the active investigational treatment.

CONCLUDE Study Q & A

  • During your visits to the study center, the study team will ask you a number of questions and perform medical tests. The following assessments will occur during the study:

    • Questions about you, your health, lifestyle, medical history, current and previous medications.

    • Measurements of your height, weight, blood pressure, heart rate and temperature.

    • Physical examination.

    • Collection of blood and stool samples.

    • Pregnancy test (if applicable).

    • ECG (electrocardiogram), which measures the electrical activity of your heart.

    • Colonoscopy/Sigmoidoscopy - both procedures use a small camera attached to a thin, flexible tube to look at the colon.

    • Biopsy - during the Colonoscopy/Sigmoidoscopy small tissue samples will be collected.

    • Complete questionnaires about your disease and how it is affecting your life.

    • Review of any recent changes in your health.

    • Administration of investigational medication/placebo.

  • Once enrolled in the study, you will be placed randomly in the active study treatment group or the placebo group by an automated system called RTSM. Neither you nor the study team will know to which treatment group you have been assigned. This ensures that the findings from the different groups will be handled in the same way. In the event of an emergency, the study team can determine which investigational medication you are taking.

  • The investigational medicine/placebo will be self-administered by you at the study center during the Induction study. You will be asked to lie on your left side while you administer the investigational medication/placebo rectally an enema. After administration, you will be asked to remain lying on your side for 30 minutes so that the study team may monitor any leakage and ensure that you are feeling well.

    During the Maintenance study, you will be provided with sufficient investigational medication/placebo to take home and administer at home in between clinic visits. YOu will be asked to keep a diary of the administration times.