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

NCT07683325 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2026-08-24

No results posted yet for this study

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).

The participants will be in the trial for a duration of up to 60 weeks, consisting of a 6-week screening period (with 2 screening visits), a 52-week treatment period, and a 2-week follow-up period. The visit frequency in the treatment period will be every 6 to 8 weeks.

Conditions

  • Fibrostenotic Crohn's Disease

Interventions

DRUG

Ontunisertib

Oral capsule

DRUG

Ontunisertib

Oral capsule

DRUG

Ontunisertib

Oral capsule

DRUG

Placebo

Matching oral capsule

Sponsors & Collaborators

  • Agomab Spain S.L.U.

    lead INDUSTRY

Principal Investigators

  • Silke Hüttner, MD · Agomab Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2028-12-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07683325 on ClinicalTrials.gov