FUZION: Efficacy and Safety of an investigational medication in participants with Fistulizing, Perianal Crohn’s Disease
The purpose of the FUZION Study is to evaluate the efficacy and safety of the investigational study medication in participants with Fistulizing, Perianal Crohn’s Disease
You may be able to take part in the FUZION study if you meet the following criteria:
- Are at least 18 years of age
- Have been diagnosed with Crohn’s Disease for at least three months
- Have at least 1 perianal fistula as a complication of your Crohn’s disease
Study description/explanation of participation:
- The study will last up to approximately two years (main study for ~48 weeks / long term extension study ~48 weeks) with visits every 4 weeks
- You may receive a placebo (containing no active medication) or the investigational medicine
- If you initially receive a placebo and you don’t 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 study medicine will be administered intravenously (into a vein) for the first three visits and subcutaneously (under the skin) thereafter.
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 medicine, 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. 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