GALAXI - A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical effectiveness (GALAXI 1), clinical and endoscopic effectiveness (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease (CD).
You may be able to take part in the GALAXI study if you meet the following criteria:
- Are at least 18 years in age
- Have been diagnosed of CD for a least 3 months
- Have moderately to severely active CD
- Have not responded to previous treatments
This program consists of 3 separate studies: the clinical efficacy (GALAXI 1), clinical and endoscopic effectiveness (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease. Each study will last approximately 48 weeks. During this time you will have study visits approximately every 4 weeks. In total there will be about 15 visits. The study medicine will be administered by injection given by intravenous (IV) infusion, bollowed by subcutaneous (SC) inection. After the study is over you may be eligible to continue in a long-term extension.
Description of Treatment or Intervention (Mechanism of Action)
The investigational study medicine being tested to see if it will reduce inflammation in the intestines.
Patient Participation Requirements
For more information on participation, including frequently asked questions visit https://galaxistudy.com
Possible Risks & 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.