If you have moderate to severe Crohn’s disease, you may want to learn more about the VIVID-1 study. This study aims to find out whether an investigational drug can reduce the symptoms of Crohn’s disease.
Crohn’s disease is an ongoing (chronic) disease that causes inflammation or ulcers in the digestive tract. Symptoms can vary, but they usually include diarrhea, stomach pain and cramping, ulcers, fever, fatigue, and difficulty absorbing certain nutrients. The worst symptom, though, is the unpredictable flare-ups.
There are a lot of treatment options available for Crohn’s flare-ups. Maybe you haven’t found the right one yet, or maybe your current treatment doesn’t work as well anymore. That’s why research is happening now on an investigational drug for adults with Crohn’s disease. The VIVID-1 study is an important step in finding an effective treatment for Crohn’s disease, and you may be able to help.
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:
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 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:
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.