Crohn’s Disease (VIVID-1 Study)

This clinical study aims to find out whether treatment with the investigational drug is effective. This is done by tracking participants’ symptoms during treatment, as well as looking for signs of Crohn’s in the digestive tract with an endoscope.

Results of treatment with the investigational drug will be compared to treatment with another medication already being used for Crohn’s, as well as an inactive drug (placebo). The drug being tested cannot be prescribed by doctors in everyday practice. Right now, this drug may only be used in research.

Certain people will qualify to participate in this study. We are looking for:

1. Adults ages 18 to 80 who have been diagnosed with moderate to severe Crohn’s disease for at least three months
2. People whose existing Crohn’s treatment:

• Is not working well enough
• Is not working anymore 
•  Has side effects they can’t tolerate

     3. People who agree to complete the study activities, including endoscopy and a daily diary entry

If you qualify, you will receive one of these study treatments:

• The drug being tested
• Another medication already being used for Crohn’s • An inactive drug (placebo)

The study treatment you receive will be decided by chance. You won’t know which medication you are taking, and the study doctor won’t either. You have a 2-in-11 chance of getting placebo. You have a > 80% chance of getting active drug, and those < 20% of patients initially getting placebo may still get on active drug if the placebo does not generate a response.

About 1,100 patients in approximately 36 countries will take part in the VIVID-1 study.

The VIVID-1 study will take up to 1 year and 5 months. It will consist of these four study periods:

• Screening period: During this period, which could last up to five weeks, the study team will decide if you qualify to participate.
• Study dosing period 1: If you qualify for the study, you will start to receive one of the three study treatments. You will receive treatment as an infusion into a vein (IV), injections under the skin, or a combination of both. Study dosing period 1 lasts 12 weeks and includes six study appointments.
• Study dosing period 2: This period lasts an additional 40 weeks and includes 10 appointments, one of which is a phone appointment.
•  Follow-up period: When the study is over, you will be asked to return to the study site for follow-up appointments. You will come back at four and 16 weeks after your final appointment in study dosing period 2.

After completing the VIVID-1 study, you may qualify to be in an optional extension study. This is a clinical study in which participants take the investigational drug over a longer period of time. If you join the VIVID-2 extension study, you will complete the after-treatment follow-up after you finish the extension study.

You will receive the study medications and procedures for the study at no cost.