The GALAXI Research Study will assess the safety and effectiveness of an investigational medicine in men and women with Crohn’s disease (CD). ‘Investigational’ means that the medicine has not been approved for a specific clinical use and is still being evaluated. During the study, you will take an investigational medicine, a medicine already approved to treat CD or placebo. During the study, you may be able to continue to take your current medication for CD, as instructed by your study physician.
To determine whether you can take part in the study, you will be invited to go to a study center to undergo medical tests and assessments. This visit will occur up to 5 weeks before the start of study treatment. If you qualify and enter the study, you will be asked to return to the study center every 4 weeks to receive the study medicine and undergo further tests (13 visits in total). At the end of 48 weeks, you may be eligible to join a long-term extension, during which you will receive the study medicine for an additional 2 years.