NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease

Summary

Many patients with Crohn's disease (CD) 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 efficacy, safety, and dose-response relationship of ontunisertib in participants with CD and symptomatic strictures, and contribute to the validation of novel endpoints to assess potential treatment benefit in patients with fibrostenosing Crohn's disease (FSCD).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Fibrostenotic Crohn's Disease

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Agomab Spain S.L.U.

Last updated on ClinicalTrials.gov

October 29, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites