STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Fibrostenotic Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT05843578
- Run by
- Agomab Spain S.L.U.
- People needed
- 103
- Starts
- 2023-08-01
- Expected to finish
- 2026-06-20
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Gemeinnutzige Salzburger Landeskliniken Betriebsgesellschaft mbH (Landeskrankenhaus Salzburg/Regional Hospital Salzburg) — Salzburg, Austria
- Medical University Of Vienna (AKH Wien) — Vienna, Austria
- Hospital Landstrasse, Department of Internal Medicine IV — Vienna, Austria
- University of Calgary — Calgary, Canada
- Gastroenterology and Internal Medicine Research Institute (GIRI) — Edmonton, Canada
- South Edmonton Gastroenterology Research Clinic — Edmonton, Canada
- Nova Scotia Health Authority — Halifax, Canada
- TIDHI Innovation Inc. — North York, Canada
- Ottawa Hospital Research Institute — Ottawa, Canada
- (G.I.R.I) GI Research Institute — Vancouver, Canada
- Aarhus University Hospital, Department of Hepatology and Gastroenterology — Aarhus, Denmark
- Bispebjerg Hospital — Copenhagen, Denmark
- Rigshospitalet - University Hospital Copenhagen — Copenhagen, Denmark
- Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.