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

Conditions

• Fibrostenotic Crohn's Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ontunisertib — DRUG
  Oral capsule
• Ontunisertib — DRUG
  Oral capsule
• Ontunisertib — DRUG
  Oral capsule
• Placebo — DRUG
  Matching oral capsule

Study Details

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.

Key Dates

First listed

Jul 6, 2026

Start date

Oct 30, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ontunisertib High
  Ontunisertib high dose
• Experimental: Ontunisertib Medium
  Ontunisertib medium dose
• Experimental: Ontunisertib Low
  Ontunisertib low dose
• Experimental: Placebo
  Matching placebo

Primary Outcome Measure

Proportion of participants achieving endoscopic passability of the ileal index stricture [ Time Frame: At week 24 ]

Central Contacts

• Agomab Clinical Operations
  0032 3318 91 70
  [email protected]

Locations (1)

Find similar trials in Bradenton, FL