STENOVA - A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

Summary

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.

Timeline

Start

2023-08-01

Primary completion

2026-06-20

Completion

2026-06-20

Outcome

Met primary endpoint

release “Part A of the STENOVA study achieved its primary endpoint , with the observed safety profile supporting further clinical development.” agomab.com ↗

Drugs

Indications