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For Crohn's Disease Study
The trial consists of four phases:
• Screening Phase (up to 5 weeks)
• Main Treatment Phase (24 weeks)
• Extension Treatment Phase (72 weeks)
• Post-Treatment Phase (12 weeks; starts after the last dose of trial medication) Participation in the GRAVITI Study is expected to last up to 109 weeks (around 2 years) Participation includes visits to the trial clinic about every 4 weeks. After Week 48, participants may have the option to do the trial visits via telemedicine contact (e.g., by video call) at every other visit starting at Week 52
For Ulcerative Colitis Study
The trial consists of four periods:
• Screening Period (up to 8 weeks)
• Main Treatment Period (24 weeks)
• Extension Period for participants who are eligible to continue on the trial medication (72 weeks)
• Follow-Up Period (12 weeks after the last dose of trial medication)
• Total possible trial duration is approximately 112 weeks (2 years and 2 months)
• Participation also includes regularly scheduled trial visits every 4 weeks for tests and procedures (approximately 28 total visits including screening and follow-up). Up to 6 visits may be conducted at home via telehealth for patients who qualify
Criteria:For Crohn's Disease Study
Are 18 years of age or older Have had a diagnosis of Crohn’s disease or fistulizing Crohn’s disease for at least 3 months Are currently experiencing a reappearance or worsening of your Crohn’s disease symptoms, called a flare, which may include:
• Frequent and/or urgent bowel movements
• Abdominal pain
• Lack of appetite
• Diarrhea Have been unsuccessful with previous medications to treat your Crohn’s disease
For Ulcerative Colitis Study
• Are at least 18 years old
• Have had a diagnosis of ulcerative colitis for at least 3 months
• Are currently experiencing a reappearance or worsening of your ulcerative colitis symptoms, called a flare, which may include:
• Frequent and/or urgent bowel movements
• Abdominal pain
• Lack of appetite
• Diarrhea
• Rectal bleeding
• Have been unsuccessful with previous medications to treat your ulcerative colitis