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A Phase 2a, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

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Trial Profile

A Phase 2a, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AGMB-129 in Patients With Fibrostenotic Crohn's Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Aug 2026

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At a glance

  • Drugs Ontunisertib (Primary)
  • Indications Crohn's disease
  • Focus Adverse reactions
  • Acronyms STENOVA
  • Sponsors AgomAb Therapeutics

Most Recent Events

  • 06 Aug 2026 According to an AgomAb Therapeutics media release, as of Feb 2026, the Data Safety and Monitoring Board has not raised any safety issue and has recommended for the OLE study to continue as per the protocol with 200mg BID ontunisertib for up to 60 weeks.
  • 06 Aug 2026 According to an AgomAb Therapeutics media release, results of the 12-week (Part A) were presented as a late-breaker at the 21st Congress of ECCO (ECCO'26) in Stockholm, Sweden in February 2026. The late-breaking presentation was also featured by Nature Reviews Gastroenterology & Hepatology as one of the highlights of ECCO'26.
  • 06 Aug 2026 According to an AgomAb Therapeutics media release, trial is ongoing with topline 48-week results from part B (OLE) expected in the coming months.

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