The study focuses on Fibrostenosing Crohn’s Disease, a form of Crohn’s disease where scar tissue causes narrowing and blockage of the intestine. The investigational medicine being examined is ontunisertib, given as oral capsules in two strength levels (200 mg and 800 mg). Participants will be randomly assigned to receive either one of the active doses or a matching placebo that looks the same but contains no active drug.
The aim is to determine whether the drug improves the ability of the intestine to open up and reduces disease activity, and to see how the different doses compare. Over a period of up to one year, participants will take the study medication each day, undergo an endoscopic examination of the intestine and a special imaging test called MRE at approximately 24 and 52 weeks, and have routine safety checks that include blood tests, vital‑sign measurements, an ECG, and physical examinations. Researchers will also track side effects, referred to as TEAEs, and use a scoring system known as SES‑CD to evaluate changes in disease severity.
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