A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease
The study is to evaluate the long-term safety of oral GED-0301 (mongersen) in subjects with Crohn's Disease.
The study is to evaluate the long-term safety of oral GED-0301 (mongersen) in subjects with Crohn's Disease.
Hospitalization for kidney stones in the Inflammatory Bowel Disease (IBD) population is common, particularly among Crohn's patients who had a small bowel resection. This patient population experiences a lifetime occurrence of kidney stone formation as high as 25% accompanied with a high rate of recurrence (the typical rate of stone formation is ~10% in the non IBD population). Giving oral calcium is used to bind oxalate in the intestine in an attempt to reduce the amount of oxalate that is absorbed into the body and to reduce urinary oxalate levels.
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of ABT-494.
This study is a clinical research study to see if the investigational medication, GED-0301, is effective in participants with active Crohn’s disease. GED-0301 (mongersen) is a drug taken by mouth that inhibits an immune response in the gut (Smad 7) that causes inflammation (or swelling).
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to anti-Tumor Necrosis Factor (TNF) therapy.