STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
Condition: Fibrostenotic Crohn's Disease · Sponsor: Agomab Spain S.L.U.
About this study
Many patients with Crohn's disease develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals. Because of these symptoms, patients often require bowel resection surgery. The objective of this clinical trial is to evaluate the safety, pharmacokinetics, and pharmacodynamics of AGMB-129 (Ontunisertib) in patients with Crohn's disease and symptomatic strictures, and whether it can have a beneficial effect on intestinal strictures. The participants will be in the Part A for a duration of up to 19 weeks including a 5 week screening period, a 12-week double-blind, placebo-controlled treatment period, and 2 week safety follow up period. Participants who continue to Part B can receive treatment for up to an additional 48 weeks, with a safety follow-up visit 2 weeks after the last dose of treatment.
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (52)
| Medical Research Center of Connecticut, LLC | Hamden, Connecticut, United States | — |
| University of Miami | Miami, Florida, United States | — |
| Digestive and Liver Center of Florida | Orlando, Florida, United States | — |
| Gastroenterology Health Partners | New Albany, Indiana, United States | — |
| Gastroenterology Health Partners | Louisville, Kentucky, United States | — |
| Louisiana Research Center | Shreveport, Louisiana, United States | — |
| University of Michigan | Ann Arbor, Michigan, United States | — |
| Mayo Clinic | Rochester, Minnesota, United States | — |
| Washington University School of Medicine | St Louis, Missouri, United States | — |
| Cleveland Clinic | Cleveland, Ohio, United States | — |
| Gastro One | Cordova, Tennessee, United States | — |
| Medical University of Graz | Graz, Austria | — |
+ 40 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05843578