The GRACE Study is divided into two parts: (1) the open-label phase and (2) the randomized-withdrawal phase. All study participants will be in the first part, but only some will be eligible to continue to the second part. Participation in the study could last up to 46 weeks and include up to 13 visits to the research site.
Screening: After you consent to participate in the study, you will need to attend a
screening visit where your study doctor will perform tests and procedures to confirm your eligibility
to take part in the study. The screening portion of the study may last up to six weeks.
First part (open-label phase): If you qualify based off the study criteria, you will receive the investigational study medicine and be in this part of the study for up to 24 weeks and will need to visit the research site approximately 10 times.
Second part (randomized-withdrawal phase): If you qualify to enter the second part,
you will have a 50/50 chance of continuing to receive the investigational study medicine or receive the
placebo and will remain in the study for an additional 12 weeks and need to visit the research site
approximately three more times.
Long-Term Extension Study: If you complete the study, and your study doctor determines
that you have benefited from the investigational study medicine, you will have the option to continue
receiving treatment in the long-term extension study.
You may be asked to return to the research site for extra visits at any time during the study if the
study doctor decides that extra assessments are needed for your safety.