The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.
Key facts
- Study ID
- NCT04985968
- Run by
- InDex Pharmaceuticals
- People needed
- 171
- Starts
- 2021-11-24
- Expected to finish
- 2023-12-20
- Last updated by the study team
- 2023-12-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Allameh Medical Corporation — Mission Viejo, California, United States
- Prospective Research Innovations Inc. — Rancho Cucamonga, California, United States
- Valiance Clinical Research — Tarzana, California, United States
- RecioMed Clinical Research Network, Inc. — Boynton Beach, Florida, United States
- MB & V Medical Research — Doral, Florida, United States
- A+ Research, Inc. — Miami, Florida, United States
- SouthCoast Research Center, Inc — Miami, Florida, United States
- I.V.A.M. Clinical & Investigational Center LLC — Miami, Florida, United States
- D&H National Research Centers, Inc. — Miami, Florida, United States
- Medical Professionals Clinical Research Center — Miami, Florida, United States
- Gastroenterology Group Of Naples — Naples, Florida, United States
- Alliance Clinical Research - Gastroenterology — Tampa, Florida, United States
- Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
- Clinical Research Institute of Michigan — Troy, Michigan, United States
- Lenox Hill Hospital — New York, New York, United States
- Carolina Digestive Health Associates, PA — Charlotte, North Carolina, United States
- Carolina Research — Greenville, North Carolina, United States
- Peters Medical Research — High Point, North Carolina, United States
- Dayton Gastroenterology — Beavercreek, Ohio, United States
- Digestive Health Associates of Texas, PA — Carrollton, Texas, United States
- Clinical Research Solution: Digestive Health Associates — Houston, Texas, United States
- Baylor College of Medicine - Gastroeneterology — Houston, Texas, United States
- Gastroenterology Associates of Northern Virginia — Fairfax, Virginia, United States
- Wisconsin Center For Advanced Research — Milwaukee, Wisconsin, United States
- Amicis Research Center — Granada Hills, California, United States
Full record on ClinicalTrials.gov
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